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Trends and Perspectives of Biological Drug Approvals by the FDA: A Review from 2015 to 2021

Alexander C. Martins
Mariana Y. Oshiro
Fernando Albericio
Beatriz G. de la Torre
Gustavo José V. Pereira
1 and
Rodrigo V. Gonzaga
School of Health Sciences, UAM, Universidade Anhembi-Morumbi, São Paulo 03101-001, Brazil
School of Chemistry and Physics, University of KwaZulu-Natal, Durban 4001, South Africa
CIBER-BBN, Networking Centre on Bioengineering, Biomaterials and Nanomedicine, Department of Organic Chemistry, University of Barcelona, 08028 Barcelona, Spain
KRISP, College of Health Sciences, University of KwaZulu-Natal, Durban 4001, South Africa
FCF-USP, School of Pharmaceutical Sciences, University of Sao Paulo, Sao Paulo 05508-000, Brazil
Centro Universitário São Camilo, São Paulo 04262-200, Brazil
FAM—Centro Universitário das Américas, São Paulo 01304-001, Brazil
Authors to whom correspondence should be addressed.
Biomedicines 2022, 10(9), 2325;
Submission received: 26 August 2022 / Revised: 12 September 2022 / Accepted: 14 September 2022 / Published: 19 September 2022
(This article belongs to the Section Drug Discovery, Development and Delivery)


Despite belonging to a relatively new class of pharmaceuticals, biological drugs have been used since the 1980s, when they brought about a breakthrough in the treatment of chronic diseases, especially cancer. They conquered a large space in the pipeline of the pharmaceutical industry and boosted the innovation portfolio and arsenal of therapeutic compounds available. Here, we report on biological drug approvals by the US Food and Drug Administration (FDA) from 2015 to 2021. The number of drugs included in this class grew over this period, totaling 90 approvals, with an average of 13 authorizations per year. This figure contrasts with previous periods, which registered between 2 and 8 approvals per year. We highlight the great potential and advantages of biological drugs. In this context, these therapeutics show high efficacy and high selectivity, and they have brought about a significant increase in patient survival and a reduction of adverse reactions. The development and production of biopharmaceuticals pose a major challenge because these processes require cutting-edge technology, thereby making the drugs very expensive. However, we believe that, in the near future, biological medicines will be more accessible and new drugs belonging to this class will become available as new technologies emerge. Such advances will enhance the production of these biopharmaceuticals, thereby making the process increasingly profitable and less expensive, thereby bringing about greater availability of these drugs.

1. Introduction

Biological drugs (or biopharmaceuticals) derive from living organisms. They are highly selective, high-cost, typically susceptible to microbial contamination, and generally temperature-sensitive drugs. They can also be used as advanced alternatives when conventional synthetic drugs no longer have the desired effect [1].
Biopharmaceuticals can be isolated from microorganisms, humans, animals or they can be isolated from compounds of nucleic acids, sugars and proteins. Here, we will address authorizations given by the U.S. Federal Drug Administration (FDA) to biologicals classified as monoclonal antibodies (mAbs), antibody–drug conjugates (ADCs), and proteins, which encompass enzymes and hormones [2]. All product references cited in this work hold a Biologics License Application (BLA) number. Although we will not include biosimilars in the quantitative analysis, they will be briefly commented on.
Advances in biological drug development by the pharmaceutical industry have given rise to new treatments to meet urgent medical needs, among them cancer. For example, regarding biologicals to treat diseases like cancer and autoimmune conditions, in 2014, four mAbs were indicated for cancer. More recently, in 2020, this figure had doubled, with eight mAbs for the treatment of this disease, while in 2021 there were five mAbs for this purpose. In the context of autoimmune diseases, in 2014, there was only one mAb and one enzyme approved, while in 2016 there were two mAbs, and in 2017 four [3,4]. It was only from 2015 onward that the number of approvals of biologicals per year jumped to a 2-digit figure as prior to 2015 such approvals did not reach 10 per year.
This retrospective observational review covers all the biologicals approved for the treatment of cancer, autoimmune conditions, and all other diseases, including rare diseases, between 2015 and 2021. It also encompasses many examples of the effectiveness of this class of drugs. We have excluded articles that mentioned the approvals of biologicals for COVID-19 and also articles about biosimilars. All the biosimilars mentioned briefly herein were found in the FDA Purple Book database.

2. Monoclonal Antibodies (mAbs)

The most common biologicals, mAbs are highly selective and they can be conjugated to chemical compounds, drugs, and toxins. They can be classified and named on the basis of their structure (Table 1), with the letter preceding the suffix -mab indicating the origin of the antibody. Murine mAbs comprise the constant and variable regions of the antibody from mice and they carry the suffix -omab in the name (Muronomab C3). Chimeric mAbs are composed of murine variable regions fused onto human constant regions, and they carry the suffix -ximab (Infliximab). Humanized mAbs are formed almost entirely by human regions of the antibody, except the complementary region, which is the antigen-binding region. This class of mAbs has the suffix -zumab (Galcanezumab). Therefore, Chimeric mAbs are more non-human based than Humanized mAbs. Fully human antibodies have the suffix -umab in their name (Adalimumab). In 1992, Muronomab C3 Orthoclone-OKT3TM, a murine mAb, was the first of such molecules to be licensed for commercialization. Studies revealed that these antibodies presented risks of patient-related immunogenicity. The immunogenicity of murine mAbs was found to be related to immune activation, which can be critical to patients, and this drove the need to evaluate this immunological trigger [5]. To tackle this issue, other classes of mAbs were developed years later [6,7]. Of note, the nomenclature of biopharmaceuticals is not limited to what is described in this work, and it is possible to find biologicals identified in a different manner in the literature (Table 1).

3. Antibody–Drug Conjugate (ADC)

One of the main components of the ADC structure is also a mAb, which serves to increase selectivity by targeting the drug to tumors. ADCs have three main components, namely the mAb, a drug or toxin, and a biodegradable linker. The latter are characterized by being acid-cleavable, protease-cleavable, and hydrolysis-cleavable, or they can be cleaved by lysosomal enzymes before being released at the target [8] (Figure 1). These conjugated drugs have high selectivity, and they limit the exposure of healthy tissues to the cytotoxic agent. By providing the link between antibody and drug, the chemical ligand has the characteristic of being stable so that the drug can travel through the body and be released into the target tissues. In addition to showing stability in physiological conditions, the cytotoxic payload must have a conjugation functional group that allows it to be released in the desired manner to the target. [9,10]. For example, Moxetumomab Pasudotox LumoxitiTM, which is used to treat capillary leukemia, is the conjugate of a fragment of an anti-CD22 mAb with a fragment of Pseudomonas exotoxin [11]. Therefore, this ADC combines the tumor-targeting capacity of the antibody and the antitumor activity of the toxic payload.

4. Proteins

This class also includes enzymes, growth hormone, IgG blockers, and also human interleukins. An example of a member of this group is Tagraxofusp ElzonrisTM, an interleukin-3 (IL-3) with a payload of a truncated diphtheria toxin used to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients [12]. Tagraxofusp ElzonrisTM binds to CD123 and then the cytotoxic diphtheria toxin is released.
Proteins can also be identified by their names. In this regard, they carry a different suffix, with -fusp for fusion proteins (for example, the previous one mentioned Tagraxofusp [13]) and -ase for enzymes, such as Calaspargase pegol AsparlasTM used for the treatment of acute lymphoblastic leukemia. When the name of a protein is accompanied by the word pegol, it indicates pegylation of the molecule [7].

5. Biosimilars and Interchangeability

To shed light on the FDA approval of biosimilars, let us take as an example the biological reference Adalimumab HumiraTM, the first antibody of fully human origin, which was approved in 2002 [7]. Between 2016 and 2021, the FDA database lists seven other Adalimumab drugs as biosimilars (Adalimumab-fkjp HulioTM, Adalimumab-adaz HyrimozTM, Adalimumab-aqvh YusimryTM, Adalimumab-bwwd HadlimaTM, Adalimumab-atto AmjevitaTM, Adalimumab-afzb AbriladaTM, Adalimumab-adbm CyltezoTM), only one of them (CyltezoTM) being interchangeable with HumiraTM. This high number of biosimilars may be explained by the fact that the authorization process is not as expensive as for reference biopharmaceuticals and there are patent rights involved, once the reference biological drug loses its right patent, a biosimilar can be developed. Manufacturers of a proposed biosimilar are not exempt from testing and must submit data proving that the drug is highly similar to the reference biopharmaceutical in structure, safety, and purity, including immunogenicity, pharmacokinetics and/or pharmacodynamics assessments. In other words, a shorter path to achieving the approval of a biosimilar does not imply a less reliable process [14].

6. Timeline for FDA-Approved Biological Drugs

The data collected in the present work point to an undeniable growth of biological therapies. In the period from 2015 to 2021, the FDA authorized new mAbs, ADCs and proteins. Of note, the total number of approvals remained in double figures every year except 2016, in which only seven biopharmaceuticals, all mAbs, were approved (Figure 2). Analysis of the data also revealed the prominence of the authorization of mAbs compared to other biologicals.
Although this work collects data from 2015 onwards, the last two years of the period of interest (2020 and 2021) were remarkable for several reasons. First, the COVID-19 pandemic promoted emergency use authorization for synthetics and biologicals, and second, the green light was given for the first biological for Alzheimer’s Disease (AD), namely Aducanumab AduhelmTM. The approval of this drug met with criticism for its cost (US$56,000/year, with a reduction to US$28,200/year after a few months) and the manner that it received such authorization [22,23,24]. Moreover, it has been reported that Aducanumab may be related to severe adverse events such as brain swelling [25]. In this regard, the European Medicines Agency (EMA) and the Pharmaceuticals and Medical Devices Agency (PMDA) withdrew marketing authorization for this drug in 2021 [26]. AD is an extremely important medical target as, according to the FDA, there has not been a new treatment for this disease since 2003 [15].
The number of mAbs authorized each year between 2015 and 2021 has never been below 50% of total approvals (2015, 69.2%; 2016, 100%; 2017, 76.9%; 2018, 64.7%; 2019, 53%; 2020, 80%; and 2021, 57.1%). The next category of drugs in terms of the number of approvals in this period is enzymes (11%), followed by ADCs (10%), proteins and fusion proteins (6%), and finally hormones (3%) (Figure 3).

7. Therapeutic Indications

7.1. Cancer

Considering all the therapeutic targets found, the approvals of biopharmaceuticals for the treatment of cancer are highlighted in the period 2015–2021. A total of 32 biologicals were authorized for the treatment of a variety of cancers (cervical cancer, lymphomas, leukemias, and other blood cancers, lung cancer, endothelial cancer, sarcomas, carcinomas, breast cancer, multiple myeloma, neuroblastoma, skin cell cancers, among others). Of these, 62.5% (20) are mAbs, 30% (9) ADCs, and 9.37% (3) fall into the class of proteins (proteins and enzymes). Of note, the biologicals for the treatment of different types of cancer varied greatly from year to year, although mAbs were on the rise. In this context, in 2015, four out of the nine approved mAbs were for cancer, and in 2016 all six mAbs were for this indication. In 2017, of the three biopharmaceuticals for cancer, two were mAbs and one was an ADC. In 2018, of the five approvals for cancer, only two were mAbs, one was an ADC, and two were proteins. In 2019, of the four approvals for this indication, only one was a mAb, while the remaining three were ADCs. In 2020, six mAbs and two ADCs were authorized for the treatment of this disease. In 2021, only one mAb was approved, while two ADCs and one enzyme received the green light. The coronavirus over the last two years may have influenced the FDA’s decisions regarding the approval of new drugs, whether synthetic products or biologicals.

7.2. Mechanisms of Action and Therapeutic Indications of ADCs and mAbs for Cancer

7.2.1. mAbs for Cancer

Both IgG1k Daratumumab DarzalexTM and the IgG1 Isatuximab SarclisaTM bind to CD38 [27,28]. Like other conventional medicines, biologicals can undergo changes. One example is DarzalexTM (given intravenously), which was modified and approved in 2020 as Daratumumab and hyaluronidase (Darzalex FasproTM) (given subcutaneously), the latter containing the same combined human mAb with a recombinant human enzyme called hyaluronidase, which enhances the absorption of injectables, allows faster infusions, and a lower rate of reactions related to infusions [29]. Both DarzalexTM and Darzalex FasproTM target CD38. Approved by the FDA in 2005, human hyaluronidase injections alter the permeability of human tissue, and they are used as an adjuvant to improve the characteristics of injectables [30]. Other examples of mAb modification include Rituximab and hyaluronidase (Rituxan HycelaTM), approved in 2017, also given subcutaneously. However, it was first approved back in 1997 by the trade name RituxanTM, being administered intravenously [31]. Trastuzumab and hyaluronidase (Herceptin HylectaTM) [32] and Pertuzumab, trastuzumab, and hyaluronidase (PhesgoTM) [30] underwent the same modification with the addition of hyaluronidase, both being administered subcutaneously and both for breast cancer. Margenza™ is directed at the same target, HER2, for breast cancer [33], and all breast cancer biologicals currently on the market were approved between 2019 and 2020.
LartruvoTM was the only drug approved for soft tissue sarcoma during the period of interest [34]. TecentriqTM, BavencioTM and ImfinziTM have the same target (PD-L1), and all three are biologicals that can be used to treat the highest number of different types of cancer [35,36,37]. PortrazzaTM targets EGFR, and RybrevantTM has the same target plus the MET proto-oncogene. Therefore, RybrevantTM is the only bispecific mAb for cancer approved to date [38,39]. Another breakthrough in the period 2015–2021 was PoteligeoTM, a first-in-class biopharmaceutical that targets the CC chemokine receptor 4 (CCR4) [40]. In this period, we found four biologicals approved for multiple myeloma, but one of them (EmplicitiTM) has a distinct mechanism of action in that it binds to the cell surface receptor signaling lymphocytic activation molecule F7 (SLAMF7), whereas DarzalexTM, Darzalex FasproTM and SarclisaTM target CD38 [27,28,29]. Table 2 lists all the mAbs for cancer approved from 2015 to 2021 and detailed information for each one.
Table 2. Monoclonal antibodies for cancer approved by the Food and Drug Administration from 2015 to 2021.
Table 2. Monoclonal antibodies for cancer approved by the Food and Drug Administration from 2015 to 2021.
Active Ingredient and Trade NamemAb ClassTargetsOriginal Approval DateManufacturerTherapeutic Indication
(Elotuzumab) [16,41]
HumanizedSLAMF72015Bristol–Myers Squibb CompanyMultiple myeloma
(Necitumumab) [16,38]
HumanEGFR 2015Eli Lilly and Comp.Squamous non-small cell lung cancer
(Daratumumab) [16,27]
HumanCD-382015Janssen Biotech, Inc.Multiple myeloma
(Dinutuximab) [16,42]
ChimericGD-22015United Therapeutic CorporationHigh-risk neuroblastoma
(Atezolizumab) [17,36,43]
HumanizedPD-L12016Genentech, Inc.HCC, SCLC, TNBC, UC, NSCLC, and melanoma
(Olaratumab) [34,43]
HumanPDGFR-α2016Eli Lilly and Comp.Soft tissue sarcoma
BavencioTM (Avelumab) [37,44]HumanPD-L12017EMD Serono, Inc.MCC, UC and RCC
(Durvalumab) [35,44]
HumanPD-L12017AstraZeneca UK Ltd.UC, Stage III NSCLC and ES-SCLC
Rituxan HycelaTM
(Rituximab and hyaluronidase) [31,44]
ChimericCD-202017Genentech, Inc.DLBCL, CLL and follicular lymphoma
(Cemiplimab) [19,45,46]
HumanPD-12018Regeneron Pharmaceuticals, Inc.CSCC, BCC, laBCC, mBCC and NSCLC
(Mogamulizumab) [19,47]
HumanizedCCR-442018Kyowa Kirin, Inc.Mycosis fungoides or Sézary syndrome
Herceptin HylectaTM
(Trastuzumab and hyaluronidase) [48,49]
HumanizedHER-22019Genentech, Inc.Breast cancer
Darzalex FasproTM
(Daratumumab and hyaluronidase) [27,50]
HumanCD-382020Janssen Biotech, Inc.Multiple myeloma
(Pertuzumab, Trastuzumab and hyaluronidase) [30,50]
HumanizedHER-22020Genentech, Inc.Early or metastatic breast cancer
Monjuvi™ (Tafasitamab) [21,51]HumanizedCD-192020MorphoSys US Inc.DLBCL
(Naxitamab) [50,52]
HumanizedGD-22020Y-mABs Therapeutics, Inc.Neuroblastoma
(Isatuximab) [28,50]
ChimericCD-382020Sanofi-AventisMultiple myeloma
(Margetuximab) [21,33]
ChimericHER-22020MacroGenics Inc.Metastatic breast cancer
(Amivantamab) [2,39]
Human mAbEGFR and MET2021Janssen Biotech, Inc.NSCLC
Jemperli™ (Dostarlimab) [2,53]HumanizedPD-12021GlaxoSmithKline LLCEndometrial cancer
CD—Cluster of Differentiation; PD-L1—Programmed Death Ligand 1; PDGFR-α—Platelet-Derived Growth Factor Receptor Alpha; EGFR—Epidermal Growth Factor Receptor; CCR—C-C Chemokine Receptor; SLAMF7—Signaling Lymphocytic Activation Molecule Family 7; GD—Glycolipid Disialoganglioside; HCC: Heptatocellular Carcinoma; TNBC: Triple-Negative Breast Cancer; SCLC: Small Cell Lung Cancer; NSCLC: Non-Small Cell Lung Cancer; BCC: Basal Cell Carcinoma; mBCC: Metastatic Basal Cell Carcinoma; CSCC: Cutaneous Squamous Cell Carcinoma; ES-SCLC: Extensive-Stage Small Cell Lung Cancer; RCC: Renal Cell Carcinoma; UC: Urothelial Carcinoma; MCC: Metastatic Merkel Cell Reactions Carcinoma; MET: a Proto-Oncogene; DLBCL: Diffuse Large B-Cell Lymphoma; and CLL: Chronic Lymphocytic Leukemia.
An important aspect of mAbs is their effectiveness compared to conventional treatments. For example, one of the main efficacy measures is overall survival (OS), and patients treated with Durvalumab, which is indicated for stage III non-small cell lung cancer, showed a higher OS than those receiving only chemotherapy (study also found in by the NCT03043872 trial number): median OS for Durvalumab + chemotherapy was 13 months while chemotherapy alone was 10 months [54].

7.2.2. Antibody–Drug Conjugates

Enfortumab Vedotin PadcevTM is the first biological to target the protein Nectin-4 [55]. Tisotumab Vedotin TivdakTM is a Biological specific for tissue factor (TF-011) and Polatuzumab Vedotin PolivyTM, an antibody whose target is the CD79b (a component of the B cell receptor). These three ADCs, which have different targets but the same suffix Vedotin, carry the same drug, namely monomethyl auristatin E (MMAE) [56,57,58]. MMAE is released into the cell after binding to the target, with subsequent induction of cell apoptosis by the drug, which also inhibits mitosis. These drugs also have different types of linkers. For example, the linker in PadcevTM is the protease-cleavable maleimidocaproyl valine-citrulline [55], while Tisotumab Vedotin has a Valine citrulline linker, which is also protease-cleavable [57]. It is interesting how these ADCs carrying MMAE have such unique targets, a feature not seen among mAbs.
Fam-Trastuzumab deruxtecan Enhertu™ targets human epidermal growth factor receptor 2 (HER2) for the treatment of gastric cancer, breast cancer and gastroesophageal junction adenocarcinoma. Its ligand is a topoisomerase inhibitor, which blocks DNA replication [32]. Sacituzumab govitecan Trodelvy™, indicated to treat solid tumors, has the hydrolysis-cleavable CL2A as the linker, and it also carries a topoisomerase inhibitor [59]. Loncastuximab tesirine ZynlontaTM includes an antibody against CD19. This antibody carries the antitumor drug pyrrolobenzodiazepine, and its linker is protease-cleavable [60].
BesponsaTM has a linker that can be cleaved by acid [61]. EnhertuTM has a protease-cleavable tetrapepitide linker [32,49]. Trodelvy™ has the hydrolysis-cleavable CL2A as linker [59]. The linker present in ZynlontaTM is also protease-cleavable [60] while that of BlenrepTM is maleimidocaproyl [62].
BesponsaTM and Lumoxiti™ target CD22, but they are indicated for different types of cancer [11,61]. They carry distinct drugs/toxins, BesponsaTM carrying Calich-DMH, an antitumor antibiotic produced by a bacterium, and LumoxitiTM being conjugated to a fragment of Pseudomonas exotoxin, also found as PE38. When internalized, PE38 stimulates apoptosis and the inhibition of protein synthesis. Table 3 shows the ADCs and information related to approval date, targets, manufacturer, name, and origin. Of note, all ADCs approved are indicated to treat cancers.
Table 3. Antibody–Drug Conjugates approved by the Food and Drug Administration from 2015 to 2021.
Table 3. Antibody–Drug Conjugates approved by the Food and Drug Administration from 2015 to 2021.
Active Ingredient and Trade NameAntibody ClassTargetsOriginal Approval DateManufacturerTherapeutic
(Inotuzumab ozogamicin) [44,61]
HumanizedCD222017Wyeth Pharmaceuticals LLCB-cell precursor ALL
(Moxetumomab pasudotox) [11,45]
MurineCD222018Innate Pharma, Inc.Hairy cell leukemia
(Enfortumab Vedotin) [55,56]
HumanNectin-42019Astellas PharmaUS, Inc.Metastatic urothelial cancer
(Polatuzumab Vedotin) [48,58]
HumanizedCD79b2019Genentech, Inc.Diffuse large B-cell lymphoma
(Fam-Trastuzumab deruxtecan) [32,48]
HumanizedHER-22019Daiichi Sankyo, Inc.Breast cancer and gastric or gastroesophageal junction adenocarcinoma
(Sacituzumab govitecan) [21,59]
HumanizedGlycoprotein Trop-22020Gilead Sciences, Inc.mTNBC
(Belantamab Mafodotin) [50,62]
HumanizedBCMA2020GlaxoSmithKline Intellectual Property Development Ltd. Multiple myeloma
(Loncastuximab tesirine) [2,60]
ChimericCD192021ADC Therapeutics SADiffuse large B-cell lymphoma
(Tisotumab Vedotin) [2,57]
HumanTissue factor (TF-011)2021Seagen Inc.Metastatic cervical cancer
TF—Tissue Factor; CD—Cluster of Differentiation; HER—Human Epidermal Growth Factor Receptor; BCMA—B-cell Maturation Antigen; ALL: Acute Lymphocytic Leukemia; mTNBC: Metastatic Triple-Negative Breast Cancer.
In 2015 and 2016, no ADCs were approved, while 2017 and 2018 registered the lowest number of authorizations of these drugs in the period of interest. In 2019, the highest number of approvals for ADCs were for the treatment of three types of cancer. In this regard, PadcevTM was authorized for the treatment of metastatic urothelial cancer [55], PolivyTM for diffuse large B-cell lymphoma [58], and EnhertuTM for breast cancer [32]. Then, the following two years registered two approvals each year. Thus, in 2020, BlenrepTM received the green light for the treatment of multiple myeloma [62] and TrodelvyTM for metastatic triple-negative breast cancer [59]. In the following year, ZynlontaTM, another drug for the treatment of large B-cell Lymphoma [60], was approved, as was TivdakTM for metastatic cervical cancer [57].
As seen earlier in this review, ADCs can carry a variety of antitumor components. Table 4 shows MMAE and other drugs that were found for the approved ADCs.
Table 4. Antibody–Drug Conjugates and their respective drugs.
Table 4. Antibody–Drug Conjugates and their respective drugs.
Drug/Toxin/ChemotherapyAntibody–Drug Conjugate
Monomethyl auristatin E
(MMAE) [56,57,58]
Enfortumab Vedotin
Tisotumab Vedotin
Polatuzumab Vedotin
Calich-DMH [61]Inotuzumab ozogamicin
Topoisomerase inhibitor [32,59]Fam-Trastuzumab deruxtecan
Sacituzumab govitecan
Pyrrolobenzodiazepine [60]Loncastuximab tesirine
fragment of Pseudomonas exotoxin [11]Moxetumomab pasudotox
Maleimidocaproyl monomethyl auristatin F (mcMMAF) [62]Belantamab mafodotin
Regarding the efficacy of ADCs, they show excellent performance with respect to OS. For example, one of the ADCs approved (Enfortumab Vedotin for advanced urothelial carcinoma) had a superior median OS of 12.88 months when compared to chemotherapy alone, with an OS of 8.97 months [56] (study also found in by NCT03474107).
Of the 32 biopharmaceuticals approved for the treatment of cancer in the period of interest, 29 are in the classes listed in Table 2 and Table 3, the rest falling into the categories of enzymes and fusion proteins (Table 5). Of note during the period was the approval of a unique treatment for Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) (Tagraxofusp ElzonrisTM), a disease for which no standard treatment had been available previously. The literature reports a better response to this drug in treatment-naïve patients than in those who had already been treated with other therapies for BPDCN, and a 90% overall response rate (ORR) in 70-year-old patients [63,64]. To date, the literature also shows limited data regarding this new treatment, and further evaluation is needed.
Table 5. Enzymes and proteins for cancer approved by the Food and Drug Administration from 2015 to 2021.
Table 5. Enzymes and proteins for cancer approved by the Food and Drug Administration from 2015 to 2021.
Active Ingredient and Trade NameBiological ClassTarget/Mechanism of ActionOriginal Approval DateManufacturerTherapeutic Indication
(Calaspargase pegol) [19,65]
Enzyme Conversion of amino acids2018Servier PharmaceuticalsALL
(Tagraxofusp) [19,64]
Fusion proteinCD-1232018Stemline Therapeutics Inc.BPDCN
Rylaze™ (Asparaginase erwinia chrysanthemi (recombinant)) [2,66]Enzyme Conversion of amino acids2021Jazz Pharmaceuticals Ireland LimitedALL and LBL
CD—Cluster of Differentiation; ALL: Acute Lymphoblastic Leukemia; LBL: Lymphoblastic Leukemia; BPDCN: Blastic Plasmocytoid Dendritic Cell Neoplasm.

8. Autoimmune Diseases

The biologics for autoimmune diseases (psoriasis, plaque psoriasis, psoriatic arthritis, multiple sclerosis, myasthenia gravis, lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and neuromyelitis optic spectrum disorder) in the period of interest included 13 biologics, 12 of which were mAbs, and a new class of biological, namely an antibody fragment (Efgartigimod alfa VyvgartTM), which is detailed in Table 6.
Table 6. Biopharmaceuticals for autoimmune diseases approved by the Food and Drug Administration from 2015 to 2021.
Table 6. Biopharmaceuticals for autoimmune diseases approved by the Food and Drug Administration from 2015 to 2021.
Active Ingredient and Trade NamemAb ClassTargets/Mechanism of ActionOriginal
Approval Date
ManufacturerTherapeutic Indication
(Secukinumab) [16,67]
HumanIL-17A inhibitor2015Novartis PharmaceuticalsPlaque psoriasis, Psa, and AS
Zinbryta™ (daclizumab) [43,68]HumanizedIL-2R inhibitor2016Biogen IncMultiple sclerosis
Taltz™ (ixekizumab) [43,69]HumanizedIL-17A inhibitor2016Eli Lilly and CompanyPlaque psoriasis and Psa
Tremfya™ (guselkumab) [18,70]HumanIL-23 and IL-17A inhibitor2017Janssen Biotech, IncPlaque psoriasis
Ocrevus™ (Ocrezilumab) [44,71]HumanizedAnti-CD-202017Genentech, IncMultiple sclerosis
Kevzara™ (sarilumab) [44,72]HumanIL-6 inhibitor2017Sanofi-Aventis U.S LLCRheumatoid arthritis
Siliq™ (brodalumab) [44,73]HumanIL-17A, IL-17F, and other IL-17 isoform inhibitors2017Valeant Pharmaceuticals Luxembourg S.à.r.lPlaque psoriasis
Ilumya™ (tildrakizumab) [45,74]HumanizedIL 23p192018Sun Pharma Global FZEPlaque psoriasis
Skyrizi™ (risankizumab) [48,75]HumanizedIL-23p19 inhibitor2019AbbVie Inc.Plaque psoriasis and Psa
(inebilizumab) [50,76]
HumanizedDepletes CD-192020Horizon Therapeutics Ireland DACNMOSD
(satralizumab) [21,77,78]
HumanizedAnti-IL -6R2020Genentech, Inc.NMOSD
(anifrolumab) [2,79]
HumanBlocks the action of type 1 interferon receptor2021AstraZeneca ABLupus erythematosus
(efgartigimod alfa) [2,80]
Human monoclonal ARGX-113 fc fragmentNeonatal Fc receptor antagonist2021Argenx BVGeneralized myasthenia gravis
IL—Interleukin; CD—Cluster of Differentiation; Psa: Psoriatic Arthritis; NMOSD: Neuromyelitis Optica Spectrum Disorder.

Mechanism of Action and Therapeutic Indications for Autoimmune Diseases

Of the approvals of autoimmune biopharmaceuticals from 2015 to 2021, six are indicated for psoriasis, plaque psoriasis, and psoriatic arthritis. Brodalumab Siliq™ is indicated for moderate to severe plaque psoriasis [73]. While this drug acts by antagonizing the IL-17A Receptor, Cosentyx™ and Taltz™ antagonize the pro-inflammatory cytokine IL-17A, which plays a role in psoriasis and Psa [67,69]. Guselkumab Tremfya™, used for the treatment of psoriasis and Psa, is an antibody that blocks the activity of two interleukins (IL-23, IL-17A) that are overexpressed in these diseases [71]. Tildrakizumab Ilumya™ is an IgG1 antibody that selectively binds to interleukin-23-p19 (IL-23A p19) [74] and, through the same mechanism, Risankizumab Syrizi™ also binds to the same p19 subunit of this interleukin. In some countries, there are trials underway to evaluate Risankizumab for the treatment of Crohn’s disease and ulcerative colitis [75,81,82].
Saphnelo™, which has a unique mechanism of action, was the only biologic found between 2015 and 2021 for the treatment of Lupus Erythematosus [79]. Sarilumab Kevzara™ is an IgG1 monoclonal antibody, the only one for rheumatoid arthritis approved within the period of interest [72]. In this regard, two biologicals with indications for multiple sclerosis were found. Zinbryta™, which is indicated only when there has been an inadequate patient response to two other DMTs (disesase-modifying therapies) [83], and Ocrelizumab Ocrevus™, were approved in 2016 and 2017, respectively [71].
Neuromyelitis optic spectrum disorder is a demyelinating disease of the CNS, optic nerve, and spinal cord. Patients with this disorder show levels of interleukin-6 (IL-6) in the cerebrospinal fluid that are above normal [78]. Enspryng™ binds to the interleukin 6 receptor (IL-6R), preventing IL-6 from binding to its receptor [77]. The other drug used to treat this condition, namely Uplizna™, binds to CD-19 [76]. mAbs commonly target interleukin receptors.

9. Other Therapeutic Indications

In the period of interest, some therapeutic indications appear only once among FDA approvals, while others appear between two to four times. Of a total of four FDA-approved mAbs for the treatment of migraine, three are humanized mAbs and only one is fully human (Table 7). The humanized ones, Vyepti™, Emgality™ and Ajovy™, have the same mechanism of action. In this regard, they bind to CGRP, a potent vasodilator, preventing it from adhering to the receptor [84,85,86]. In contrast, the fully human antibody Aimovig™ binds to CGRPR, preventing the molecule from binding to the receptor [87].
Table 7. Monoclonal antibodies for migraine approved by the Food and Drug Administration from 2015 to 2021.
Table 7. Monoclonal antibodies for migraine approved by the Food and Drug Administration from 2015 to 2021.
Active Ingredient and Trade NamemAb ClassTarget/Mechanism of ActionOriginal Approval DateManufacturer
Emgality™ (Galcanezumab) [45,87]HumanizedCGRP antagonist2018Eli Lilly and Company
Ajovy™ (Fremanezumab) [45,86]HumanizedCGRP antagonist2018Teva Branded Pharmaceutical Products R&D, Inc.
Aimovig™ (Erenumab) [45,87]HumanCGRPR antagonist2018Amgen, Inc.
Vyepti™ (Eptinezumab) [21,84]HumanizedCGRP antagonist2020Lundbeck Seattle Pharmaceuticals, Inc.
CGRP: Calcitonin Gene-Related Peptide; CGRPR: Calcitonin Gene-Related Peptide Receptor.
For asthma and severe asthma (Table 8), two fully human antibodies were approved from 2015 to 2021. Dupixent™ is an antibody directed against the α subunit of the interleukin 4 receptor (IL-4R-α) [88], and the Tezsipre™ blocks thymic stromal lymphopoietin (TSLP), which plays a key role in asthma [89,90]. Furthermore, in the same period, three humanized antibodies received the green light. In this regard, Nucala™ and Cinqair™ are mAbs against IL-5 [91,92], while Fasenra™ acts by binding to the α subunit of the receptor of IL-5 (IL-5R-α) [90,93].
Table 8. Monoclonal antibodies for asthma and severe asthma approved by the Food and Drug Administration from 2015 to 2021.
Table 8. Monoclonal antibodies for asthma and severe asthma approved by the Food and Drug Administration from 2015 to 2021.
Active Ingredient and Trade NamemAb ClassTarget/Mechanism of ActionOriginal Approval DateManufacturer
(Mepolizumab) [16,91]
HumanizedIL-52015GlaxoSmithKline LLC
(Reslizumab) [43,92]
HumanizedIL-52016Teva Respiratory LLC
(Benralizumab) [44,93]
HumanizedIL-5R-α2017AstraZeneca AB
(Dupilumab) [44,88]
HumanIL-4R-α2017Regeneron Pharmaceuticals, Inc.
(Tezepelumab) [2,90]
HumanBlocks TSLP2021AstraZeneca AB
IL: Interleukin; IL-R-α: Interleukin Receptor α; TSLP: Thymic Stromal Lymphopoietin.
One of the key aspects of biologicals is their potential for the treatment of rare diseases, such as type 2 neuronal ceroid lipofuscinosis, which causes symptoms ranging from seizures and loss of motor coordination to vision failure. The diagnosis of this condition can be delayed due to the similarity of symptoms with other diseases. This disease causes blindness in children, a patient cohort that can make it difficult to conduct clinical trials due to a smaller population for initial studies [94]. For this disease, also known as Batten’s disease, only one biological, an enzyme (Cerliponase alfa Brineura™), was approved during the period of interest [95].
The 2021 Biological of the year is Aducanumab Aduhelm™, which was authorized in the midst of the COVID-19 pandemic through an accelerated FDA approval, despite controversy regarding phase three studies, which showed that the drug is associated with a decrease in beta-amyloid plaques. However, these studies have not proved satisfactorily that the drug delays cognitive and functional decline in patients with AD. New FDA submissions of biologicals to treat AD will soon emerge, such as Lecanemab and Donanemab, which are currently in the testing phase. However, these two drugs still need further supporting clinical evidence to compete with Aducanumab and enter the market [23,96,97]. As mentioned earlier, the EMA withdrew marketing authorization for Aducanumab.
Between 2015 and 2021, biologicals were also approved for the treatment of Bacillus anthracis (Obiltoxaximab Anthim™), Pseudomembranous Colitis (Bezlotoxumab Zinpala™), Hemophilia A (Emicizumab Hemlibra™), Sly Syndrome (Vestronidase alfa Mepsevii™), X-linked hypophosphatemic rickets (Burosumab Crysvita™), neurotrophic keratitis (Cenegermin Oxervate™), drug-resistant HIV-1 (Ibalizumab Trogarzo™), phenylketonuria (Pegvaliase Palynziq™), temporary smoothing of fine lines (Prabotulinumtoxin Jeuveau™), growth deficiency (Somapacitan Sogroya™, Lonapegsomatropin Skytrofa™), and Ebola virus (Atoltivimab, Maftivimab, and Odesivimab Inmazeb™ and Ansuvimab Ebanga™), among others (Table 9). Within the context of ‘biological treatment’, it can be concluded that one of the perspectives is to increasingly promote options for the treatment of patients with chronic diseases, including rare conditions [98]
Table 9. Other biologicals approved by the Food and Drug Administration from 2015 to 2021.
Table 9. Other biologicals approved by the Food and Drug Administration from 2015 to 2021.
Active Ingredient and Trade NameBiological ClassTarget/Mechanism of ActionOriginal Approval DateManufacturerTherapeutic Indication
(parathyroid hormone) [16,99]
HormoneSupplies parathyroid hormone2015NPS Pharmaceutical Inc.Control of hypocalcemia in hypoparathyroidism
(Alirocumab) [16,100]
Human mAbInhibits PCSK9 from binding to LDLR2015Regeneron Pharmaceutical Inc.High cholesterol
(Evolocumab) [16,101]
Human mAbInhibits PCSK9 from binding to LDLR2015Amgen Inc.High cholesterol
(insulin degludec) [16]
Human insulinStimulates peripheral glucose intake2015Novo Nordisk Inc.Improves glucose control in diabetes mellitus
(Idarucizumab) [16,102]
Humanized mAb fragmentBinds to dabigatran and neutralizes its anticoagulant effects2015Boehringer Igelheim Pharm. Patients treated with PradaxaTM when the reversal of anticoagulant effect is needed
(Asfotase alfa) [16,103]
Enzyme Replacement of TNSALP upon asfotase alfa2015Alexion Pharmaceuticals, Inc.Hypophosphatasia
(Sebelipase alfa) [16,104]
Enzyme Catalyzes the lysosomal hydrolysis of cholesteryl and triglycerides2015Alexion Pharmaceuticals, Inc.Lysosomal Acid Lipase deficiency
(Obiltoxaximab) [43,105]
Humanized mAbActs against the protective antigen of Bacillus anthracis2016Elusys Therapeutics, Inc.Anthrax
(Bezlotoxumab) [43,106]
Human mAbBinds to Clostridium difficile toxin B2016Merck Sharp & Dohme Corp.Clostridium difficile infection
(Emicizumab) [44,107,108]
Humanized mAbFactor X and factor IXa 2017Genentech, Inc.Hemophilia A
(Cerliponase alfa) [44,95]
Enzyme Hydrolytic lysosomal N-terminal tripeptidyl peptidase2017BioMarin Pharmaceutical Inc.Neuronal CLN2
(Vestronidase alfa) [44,109]
EnzymeDegrades GAG2017Ultragenyx Pharmaceutical Inc.MPS VII, Sly syndrome
(Burosumab) [45,110]
Human mAbInhibits FGF232018Kyowa Kirin, Inc.X-linked dominant hypophosphatemic rickets
(Cenegermin) [45,111]
Protein Important nerve growth factor for the survival of neurons2018Dompé farmaceutici S.p.A.Neurotrophic keratitis
(Elapegademase) [45,112]
Pegylated enzymeExternal supply of ADA enzyme2018Chiesi USA, Inc.ADA-SCID
(Emapalumab) [45,113]
Human mAbNeutralizes Interferon gamma (IFNγ)2018Swedish Orphan Biovitrum AB (publ)Hemophagocytic lymphohistiocystosis
(Ibalizumab) [45,114]
Humanized mAbViral entry inhibitor, blocking viral entry into CD4 cells 2018Theratechnologies Inc.Multidrug-resistant HIV-1
(Lanadelumab) [45,115]
Human mAbBinds to plasma kallikrein2018Takeda Pharmaceuticals U.S.A., Inc.Hereditary angioedema attacks
(Pegvaliase) [45,116]
Pegylated enzyme Conversion of amino acid into ammonia and trans-cinnamic acid2018BioMarin Pharmaceutical Inc.Phenylketonuria
(Ravulizumab) [45,117]
Humanized mAbInhibits cleavage of C5 to C5a and C5b2018Alexion Pharmaceuticals, Inc.PNH and atypical hemolytic uremic syndrome
(Brolucizumab) [48,118]
Humanized mAbInhibits VEGF2019Novartis Pharmaceuticals Corp.Wet age-related macular degeneration
(Caplacizumab) [48,119]
Humanized mAbInhibits interactivity vWF-platelets, reducing platelet adhesion2019Ablynx NVaTTP
(Crizanlizumab) [48,120]
Humanized mAbBinds to P-Selectin2019Novartis Pharmaceuticals Corp.Prevention of VOC in Sickle cell disease
(Romosozumab) [48,121]
Humanized mAbInhibits sclerostin, increasing bone formation 2019Amgen, Inc.Osteoporosis in postmenopausal women
(Luspatercept) [48,122]
Fusion proteinDiminishes Smad-2/3 signaling pathway2019Celgene Corp., a Bristol-Myers Squibb CompanyAnemia in β-thalassemia and myelodysplastic sydromes
(Prabotulinumtoxin) [48,123]
Neurotoxin proteinInhibits the release of acetylcholine in nerve terminals2019Evolus Inc.Temporary improvement of grabellar and frown lines
(Ansuvimab) [50,124]
Human mAbInhibits Ebola virus from binding to NPC1 receptor2020Ridgeback BiotherapeuticsEbola virus
(Atoltivimab, Aaftivimab, Odesivimab) [50,125]
Human mAbsInhibits Zaire Ebola virus2020Regeneron Biopharmaceuticals, Inc.Ebola virus
(Somapacitan) [50,126]
Protein Replacement of endogenous growth hormone2020Novo Nordisk Inc.Growth hormone deficiency
(Teprotumumab) [50,127]
Human mAbInhibits Insulin-like growth factor-1 receptor2020Horizon Therapeutics Ireland DACThyroid eye disease
(Aducanumab) [2,96]
Human mAbAnti-amyloid beta2021Biogen, Inc.Alzheimer’s Disease
(Tralokinumab) [99,128]
Human mAbBinds to IL-13 and inhibits it from binding to IL-13R α1 and α2 subunits2021LEO Pharma A/SAtopic dermatitis
(Ropeginterferon alfa) [2,129]
Pegylated enzymeType I interferon, it binds to IFANR2021PharmaEssentia CorporationPolycythemia vera
(Evinacumab) [99,130]
Human mAbInhibits ANGPTL32021Regeneron Pharmaceuticals, Inc.Homozygous familial hypercholesterolemia
(Avalglucosidade alfa) [99,131]
Enzyme External source of GAA2021Genzyme CorporationGlycogen storage disease type 2 (Pompe disease)
(Lonapegsomatropin) [99,132]
Pegylated hormoneBinds to the GH receptor2021Ascendis Pharma Endocrinology Divison A/SGrowth hormone deficiency
GAG: Glucuronate-Containing Glycosaminoglycan; CD: Cluster of Differentiation; IL-R: Interleukin Receptor; LDLR: Low Density Lipoprotein Receptor; TNSALP: Tissue-Nonspecific Alkaline Phosphatase; Neuronal CLN2: Ceroid Lipofuscinosis Type 2; MPS: Mucopolysaccharidosis; ADA-SCID: Adenosine Deaminase Severe Combined Immunodeficiency; VOC: Vaso-Occlusive Crisis; aTTP: Acquired Thrombotic Thrombocytopenic Purpura; NPC1: Niemann-Pick C1 Receptor; FGF: Fibroblast Growth Factor; PNH: Paroxysmal Nocturnal Hemoglobinuria; VEGF: Vascular Endothelial Growth Factor; IFANR: Interferon α Receptor; ANGPTL3: Angiopoietin-like 3; GAA: Acid α-Glucosidase; GH: Growth Hormone; PCSK9: Proprotein Convertase Subtilisin Kexin Type 9.

10. Discussion

The period 2015 to 2021 witnessed a growth in FDA approval of biologicals in general, with mAbs being the class with the greatest presence. During this period, the number of authorizations of biopharmaceuticals remained in the double figures, except in 2016, when only seven were given the green light. The years 2020 and 2021 did not show considerable variation, with one less biological being approved in 2021 than in 2020, while 2018 was the year with the highest number of approvals. Of note, even in the midst of the COVID-19 pandemic, the potential for these therapies to receive approval remained steady.
From the perspective of the origin of the biologicals, more humanized antibodies were approved than fully human, followed by chimerics, and only one biopharmaceutical from the murine class—an ADC. The authorization of only one murine mAb could be because these biologicals already posed a risk of immunogenicity to patients decades ago [5].
Among the therapeutic indications for which biopharmaceuticals were authorized in the period of interest, some appear to be more common targets. In this regard, the most common therapeutic indication was cancer. This can be explained by the fact that cancer is one of the main causes of death worldwide and biopharmaceuticals can be conjugated to drugs, thereby targeting cancer cells more selectively, and, importantly, decreasing toxicity. The latter aspect is highly relevant as most antitumor treatments are toxic. Of the 90 biologicals approved, 34% (32) (half of these being mAbs) target different types of cancer. Of note, many of the mAbs and protein classes approved were indicated for cancer. However, other therapeutic indications were also found for these drugs. In contrast, all the ADCs approved during the period of interest were for the treatment of cancer. In this regard, three ADCs were authorized in 2019, two in 2020, and two in 2021, in contrast to only one approval in 2017 and one in 2018. Although the same cytotoxic payload was repeated in some ADCs, all the antibody classes were present within the ADCs, which is highly significant. Other classes of drugs showed a much lower rate of approval. However, important ones, such as the fusion protein ElzonrisTM, the first approval for BPDCN [12], were a real breakthrough.
Biological medicines show high selectivity and high versatility and are therefore valuable. Their versatility is reflected in indications that range from the treatment of chronic or rare diseases to more aesthetic purposes such as the treatment of frown lines. These drugs offer great potential to be exploited for other therapeutic indications beyond what they were initially authorized for. In this regard, they offer a solid starting point from which to explore their capacity in clinical trials. For example, over the years, new applications have been discovered for Adalimumab HumiraTM, and today this drug has more than ten therapeutic indications listed in the directions of use [133]. Daratumumab DarzalexTM is also undergoing evaluation for other types of cancer, including refractory or relapsed non-Hodgkin’s Lymphoma [27]. mAbs can also be conjugated to toxins or drugs without compromising healthy tissues around the target fragment or at least minimizing effects in other tissues [134]. Apart from mAbs, we found that potential to be further evaluated for other therapeutic indications also in the antibody namely Efgartigimod VyvgartTM in the future [80].
Regarding AduhelmTM, although its average annual price is being criticized, the next drug approved for AD could have excellent financial potential given that the last innovation in the treatment of this condition approved was in 2003. In addition, given the average price of mAbs and the challenge to find a therapeutic innovation for this neurodegenerative disease, any new therapy would undoubtedly carry with it a significant cost. As seen in this work, the authorizations of biologicals for certain therapeutic indications grew considerably in the period 2015–2021, with mAbs as the category that received the most approvals by the FDA.
Between 2015 and 2021, in addition to the increase in the number of drug approvals, several breakthroughs and innovations took place, such as Aducanumab AduhelmTM, although still controversial, and also Tagraxofusp ElzonrisTM, which the FDA granted the status of Orphan Drug to treat rare diseases. In 2021, we witnessed the authorization of a different class of biological, Efgartigimod alfa VyvgartTM, an antibody fragment that also has Orphan Drug status [80], and the bispecific antibody approved within the period of interest HemlibraTM. Of note only two bispecific antibodies were approved in the period of interest HemlibraTM and RybrevantTM.
Although 2021 was not the year with the highest number of biological drug authorizations, 14 did obtain the green light in the midst of the COVID-19 pandemic, a number that was still above the annual average over the period addressed in this review.

11. Conclusions

In the period 2015–2021, cancer continued to be the main target, but there was increasing interest in discovering new ways and new targets, reflected, for example, by a new class of biological as a fragment of an antibody (Efgartigimod) [80], the first therapy targeting Nectin-4 (Enfortumab Vedotin) [55,56]. This is the first direct therapy to date for BPDCN and also the first treatment to target CD123 [63,64], while Aducanumab is the first drug for AD whose target is amyloid-beta.
The pharmaceutical industry is becoming increasingly aware that living organisms are an excellent source of inspiration.
However, one of the great challenges for the development of biopharmaceuticals is the high technology required to produce these drugs, which makes them very expensive. We believe that, in the near future, this class of drugs will become increasingly accessible and new drugs will be developed. Moreover, more biosimilars will become accessible thanks to the development of new technologies that will impact production. These advancements will make these drugs increasingly more profitable and less expensive, which in turn will widen the accessibility of biological therapies, thereby expanding the therapeutic arsenal and transforming the management of diseases for which no treatment is available or diseases for which current treatments are not effective.

Author Contributions

Conceptualization, A.C.M., M.Y.O., F.A., B.G.d.l.T., G.J.V.P. and R.V.G.; formal analysis, A.C.M. and M.Y.O.; investigation, A.C.M. and M.Y.O.; writing—original draft preparation, A.C.M. and M.Y.O.; writing—review and editing, all authors. All authors have read and agreed to the published version of the manuscript.


This work was partially funded by National Research Foundation (NRF) (Blue Sky’s Research # 120386).

Institutional Review Board Statement

Not applicable.

Informed Consent Statement

Not applicable.

Data Availability Statement

Not applicable.

Conflicts of Interest

The authors declare no conflict of interest.


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Figure 1. Schematic of the structure of an antibody–drug conjugate (ADC).
Figure 1. Schematic of the structure of an antibody–drug conjugate (ADC).
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Figure 2. Biologicals approved by the Food and Drug Administration (FDA) from 2015 to 2021 [2,15,16,17,18,19,20,21].
Figure 2. Biologicals approved by the Food and Drug Administration (FDA) from 2015 to 2021 [2,15,16,17,18,19,20,21].
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Figure 3. Percentage of new biopharmaceuticals approved by the Food and Drug Administration (U.S. FDA) from 2015 to 2021 [2,17,18,19,20,21].
Figure 3. Percentage of new biopharmaceuticals approved by the Food and Drug Administration (U.S. FDA) from 2015 to 2021 [2,17,18,19,20,21].
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Table 1. Nomenclature of mAb-based biologicals according to the origin of the antibody [6].
Table 1. Nomenclature of mAb-based biologicals according to the origin of the antibody [6].
Stem of BiologicalsSubstem B of BiologicalsExamples of Biologicals
Suffix -mab
(monoclonal antibodies)
-u- (human)Adalimumab
-zu- (humanized)Morgamulizumab
-xi- (chimeric)Dinutuximab
-o- (murine)Muronomab
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Martins, A.C.; Oshiro, M.Y.; Albericio, F.; de la Torre, B.G.; Pereira, G.J.V.; Gonzaga, R.V. Trends and Perspectives of Biological Drug Approvals by the FDA: A Review from 2015 to 2021. Biomedicines 2022, 10, 2325.

AMA Style

Martins AC, Oshiro MY, Albericio F, de la Torre BG, Pereira GJV, Gonzaga RV. Trends and Perspectives of Biological Drug Approvals by the FDA: A Review from 2015 to 2021. Biomedicines. 2022; 10(9):2325.

Chicago/Turabian Style

Martins, Alexander C., Mariana Y. Oshiro, Fernando Albericio, Beatriz G. de la Torre, Gustavo José V. Pereira, and Rodrigo V. Gonzaga. 2022. "Trends and Perspectives of Biological Drug Approvals by the FDA: A Review from 2015 to 2021" Biomedicines 10, no. 9: 2325.

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