FDA Approvals of Biologics in 2022

Abstract

The year 2022 witnessed the control of the COVID-19 pandemic in most countries through social and hygiene measures and also vaccination campaigns. It also saw a decrease in total approvals by the U.S. Food and Drug Administration (FDA). Nevertheless, there was no fall in the Biologics class, which was boosted through the authorization of 15 novel molecules, thus maintaining the figures achieved in previous years. Indeed, the decrease in approvals was only for the category of small molecules. Monoclonal antibodies (mAbs) continued to be the drug class with the most approvals, and cancer remained the most targeted disease, followed by autoimmune conditions, as in previous years. Interestingly, the FDA gave the green light to a remarkable number of bispecific Biologics (four), the highest number in recent years. Indeed, 2022 was another year without the approval of an antimicrobial Biologic, although important advancements were made in targeting new diseases, which are discussed herein. In this work, we only analyze the Biologics authorized in 2022. Furthermore, we also consider the orphan drugs authorized. We not only apply a quantitative analysis to this year’s harvest, but also compare the efficacy of the Biologics with those authorized in previous years. On the basis of their chemical structure, the Biologics addressed fall into the following classes: monoclonal antibodies; antibody-drug conjugates; and proteins/enzymes.

Trends in the Development of Antibody-Drug Conjugates for Cancer Therapy

“…The global market share of ADC R&D and therapeutics is growing rapidly, with eight ADCs receiving FDA approval for therapeutic use from 2019 to 2022 [10,90]. The human epidermal growth factor receptor 2 (HER2) and trophoblast cell-surface antigen 2 (TROP2) targets acco [91,92].…”

Impact of Excipient Extraction and Buffer Exchange on Recombinant Monoclonal Antibody Stability

“…Biopharmaceutical products have revolutionized healthcare and have emerged as more effective (than the conventional small molecule-based pharmaceutical products) therapies for management of complex and otherwise difficult to manage diseases, including cancer, arthritis, and autoimmune disorders . The active pharmaceutical ingredient (API) in a biologic formulation may be a (i) protein such as a monoclonal antibody (mAb), (ii) an attenuated form of a microbe, such as a vaccine, (iii) an oligonucleotide, or (iv) genes, cells, and tissues in the emerging advanced medicinal therapy products. − Numerous protein therapeutic products have been approved, including monoclonal antibodies (mAbs), antibody-drug conjugates, bispecific antibodies, and fusion proteins. , Among these, mAb products are the most popular, evident from the number of approvals each year . However, the complex production process involved in mAb manufacturing poses affordability and accessibility challenges, especially in developing economies …”

“… 5 , 6 Among these, mAb products are the most popular, evident from the number of approvals each year. 7 However, the complex production process involved in mAb manufacturing poses affordability and accessibility challenges, especially in developing economies. 8 …”

Stimuli-Responsive Hydrogels for Protein Delivery

“…One year later, proteins accounted for about 25% of the 53 FDA-approved drugs [16]. The authorization of proteins in 2022 increased slightly compared to 2021 (five vs. four, respectively) [17]. Common therapeutic proteins include the fastest growing class of monoclonal antibodies, enzymes, hormones, growth factors, anticoagulants, and fragment crystallizable (Fc) fusion proteins, among others [18,19].…”