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4 BioPharm International ® Emerging Therapies eBook September 2023 www.biopharminternational.com A s of this article's writing, FDA has approved 36 novel therapies in 2023, 13 of which are biologics (1). Relative to the novel therapies approved from Jan. 1–Sept. 8, 2022, this rep- resents a year-over-year change of 19 total approvals and eight biologics (2). While the total number isn't all that surprising—there were 37 novel approvals in that same range in 2021 (3)—the rise in number and propor- tion of approved biologics is worth noting. This trend supports the exponential growth in inter- est in biologics; between COVID-19 vaccines launching messenger RNA (mRNA) therapies into the limelight and the rising potential for personalized cancer vac- cines, biologics have captured the attention of scientists and investors alike. And for investors in particular, there is additional incentive to invest in biologics treatments due to the new exclusivity periods introduced in the In- flation Reduction Act, which give biologic treatments four more years of manufacturer exclusivity relative to small-molecule alternatives (4). In tandem with this growing interest, market re- search firms are estimating the biologics market will grow to anywhere from $506 (5) to $719 billion (6) by the end of the decade. As a major market force, it is import- ant to take stock of what biologics are being approved, as these decisions can provide insight into what the immediate future of the market might look like. The following are some highlights of novel therapies either in development or approved for 2023. Oncology therapies Of the 13 approved biologics, nearly half of them fall into the oncological therapeutic category: AbbVie's Epinkly (epcoritamab-bysp), Genentech's Columvi (glofitam- ab-gxbm), Incyte's Zynyz (retifanlimab-dlwr), Janssen's Talvey (talquetamab-tgvs), Pfizer's Elrexfio (elrana- tamab-bcmm), and BioLineRx's Aphexda (motixa- fortide). Notably, half of these biologics—Talvey and Elrexfio—treat multiple myeloma. Of the remain- ing three, Incyte's retifanlimab-dlwr is intended for A Growing Biologics Market Grant Playter was previously associate editor, and Daria Husni is assistant editor, both with BioPharm International ® . As more novel therapy approvals trend towards biologics, it is important to take stock of what treatments are shaping the future of the market. MIKHAIL - STOCK.ADOBE.COM