Amidst the pandemic, 2021 saw several drug approvals and emergency use authorizations (EUA) by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) in both the small molecule and biologic drugs categories. Approvals include new molecular entities (NMEs) that gained marketing authorization for the first time, as well as expanded therapeutic indications, new dosage forms, novel formulations, and biosimilars. In the light of COVID-19, much of the biologic EUAs pertain to vaccines and anti-viral drugs against the SARS-CoV-2 virus. In addition, a number of breakthrough innovations have been approved for rare diseases, which is consistent with the current shift towards speciality drugs in the pharma industry.
- A breakthrough therapy designation is for a drug that treats a serious or life-threatening condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant endpoint(s) over available therapies.
- A first-in-class drug is an innovative drug that uses a new and unique mechanism of action for treating a medical condition.
- An orphan drug is intended for the treatment, prevention or diagnosis of life-threatening or chronically debilitating condition that is rare or where the medicine is unlikely to generate sufficient profit to justify the research and development costs.
The US FDA’s Center for Drug Evaluation and Research (CDER) approved 42 drugs in total, of which a number of protein and antibody-based drugs, including antibody-drug conjugates (ADCs) and bispecifics, were given licensure. Interestingly, quite a few of these biologics were designated as first-in-class and used the accelerated approval pathway, unlike in previous years, including the most widely administered miRNA vaccine for COVID-19. In comparison, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued positive recommendations for 57 new drugs, out of which 36 gained marketing authorizations. These included small molecule drugs, biologics and vaccines. Some of the notable protein drugs and therapeutic antibody drugs approved by FDA and EMA in 2021 are mentioned below.
Therapeutic antibody approvals in 2021
- Sotrovimab, Regdanvimab and Casirivimab + Imdevimab, are therapeutic mAbs that were approved for COVID-19 treatment. These mAbs had received marketing authorization in the EU and EUA in the US. However, with the emergence and predominance of the Omicron variant, which is resistant to these mAbs, the EUAs have been revised. Read more on COVID-19 mAb cocktails and mAbs against Omicron.
- Adacanumab is a recombinant fully-human IgG1 directed against amyloid-beta. The US FDA approved it in June 2021 to become the first and only drug for Alzheimer’s disease that targets the underlying disease pathology, the aggregation of amyloid-beta plaques in the brain. However, the approval application is still under evaluation by the EMA.
- Bimekizumab is a dual specific humanized monoclonal antibody designed to bind to a peptide region that both IL-17A and IL-17F share. The EMA approved it in August 2021 for treating moderate-to-severe plaque psoriasis. Biologics License Application (BLA) for bimekizumab is currently under review by the US FDA.
- Evinacumab is a fully human mAb that targets angioprotein-like protein 3 (ANGPTL3) blockade, thereby reducing low-density lipoproteins (LDL-C) levels. It was approved by the US FDA in February 2021 as a first-in-class drug for a rare type of high cholesterol condition called homozygous familial hypercholesterolemia (HoFH). The drug was designated a breakthrough therapy and classified as an orphan drug.
- Amivantamab is a fully human bispecific antibody targeting the Epidermal growth factor receptor (EGFR) and Mesenchymal–epithelial transition (MET). The US FDA approved it in May 2021 as a breakthrough innovation, the first treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor EGFR exon 20 insertion mutations. In the EU, the mAb has received a CHMP recommendation for conditional approval in October 2021.
- Dostarlimab is a humanized IgG4 that blocks programmed death receptor-1 (PD-1) signalling. US FDA and EMA approved it in April 2021 for mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer.
- Loncastuximab-Tesirine is an antibody-drug conjugate (ADC) comprising humanized mAb targeting CD19 conjugated to a pyrrolobenzodiazepine (PBD)-based cytotoxic warhead. It was approved under an accelerated pathway by the US FDA to treat patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL).
- Tisotumab-Vedotin is another ADC approved by the US FDA in September 2021. It is a first-in-class drug approved to treat recurrent or metastatic cervical cancer. The ADC targets tissue factor (TF) and delivers monomethyl auristatin-E, the cytotoxic payload, into cancer cells.
- Anifrolumab is a first-in-class mAb drug targeting type I interferon (type I IFN) receptor approved to treat moderate to severe systemic lupus erythematosus (SLE). Anifrolumab was granted approval by the US FDA in September 2021 and has been recommended for marketing authorization by EMA.
- Tralokinumab is a humanized IgG1 mAb that targets OX40. The US FDA approved it in December 2021 to treat moderate-to-severe atopic dermatitis.
- Tezepelumab is a human mAb designed to block thymic stromal lymphopoietin (TSLP). It is a first-in-class drug approved by the US FDA in December 2021 as an add-on maintenance therapy for severe asthma.
In addition, a few mAb drugs that were approved by the US FDA in the previous years have gained marketing authorization in the EU in 2021. These include:
- Tafasitamab – Anti-CD19 (Humanized IgG1) approved for DLBCL
- Satralizumab – Anti-IL-6R (Humanized IgG2) approved for Neuromyelitis optica and neuromyelitis optica spectrum disorders
- Sacituzumab Govitecan – Anti- TROP-2 (Humanized IgG1 ADC) approved for Triple-negative breast cancer
- [fam]-Trastuzumab Deruxtecan – Anti-HER2 (Humanized IgG1 ADC) approved for HER2 positive breast cancer
- Moxetumomab Pasudotox – Anti-CD22 (Murine IgG1 dsFv immunotoxin) approved for Hairy cell leukemia
Other Protein and Oligomer therapeutics
- Avalglucosidase Alfa is a recombinant enzyme replacement therapy for the rare Glycogen storage disease type II, also called Pompe disease, which arises due to the deficiency in lysosomal acid alpha-glucosidase enzyme. The drug was designated orphan status by FDA and EMA and granted breakthrough therapy status by FDA. EMA’s CHMP adopted a positive opinion in July 2021.
- Casimersen is an antisense phosphorodiamidate morpholino oligonucleotide (PMO), the first therapy for Duchenne muscular dystrophy (DMD) patients with a confirmed dystrophin gene mutation that is amenable to exon 45 skipping. It was approved by the US FDA as an orphan drug in February 2021 with a breakthrough designation.
- Pegcetacoplan is a peptide drug that binds to complement protein C3 and its activation fragment C3b. It received an orphan designated for the rare disease, paroxysmal nocturnal hemoglobinuria (PNH), and was granted approval by US FDA in May 2021 and EMA in October 2021.
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- US FDA. https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2021
- European Medicines Agency. https://www.ema.europa.eu/en/committees/chmp/chmp-agendas-minutes-highlights
- tribecaknowledge.com. https://www.tribecaknowledge.com/blog/2021-new-drug-approvals-review-of-new-fda-and-ema-marketing-authorisations
- maxval.com. https://www.maxval.com/blog/therapeutic-biologic-product-approvals-in-2021/
- The Antibody Society. Therapeutic monoclonal antibodies approved or in review in the EU or US. (Accessed 26 Jan 2022); antibodysociety.org.