On April 26th 2024, the US FDA announced the approval of their 50th Biosimilar product, 14 years following the introduction of the Biologics Price Competition and Innovation Act (BPCIA). This significant milestone was celebrated by the publication of an article by Sarah Yim (Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars), Hilary Marston (Chief Medical Officer) and Patrizia Cavazzoni (Director, Centre for Drug Evaluation and Research) in FDA Voices:- A Milestone in Facilitating the Development of Safe and Effective Biosimilars.
These 50 US approved Biosimilars cover just 15 different reference biologics, out of many more possible patent-expiring molecules, and treat illnesses including rheumatoid arthritis, inflammatory bowel disease, some cancers, psoriasis, diabetes, macular degeneration, osteoporosis, and more.
The two Biosimilar products granted BLA approval in April 2024 were Selarsdi (ustekinumab-aekn, Alvotech USA, Inc) a version of Johnson & Johnson/Janssen’s immunology drug Stelara at #49 on the list and Hercessi (trastuzumab-strf, Accord Biopharma Inc.) a version of Genentech’s Herceptin, at #50. This is the first biosimilar product for Accord BioPharma, developed and manufactured by its partner Shanghai Henlius and will be the sixth trastuzumab to enter the market.
At the same time as this announcement, the Agency also updated and re-released their Biosimilars Action Plan (BAP), first released in 2018. They reported that the 2018 Action Plan deliverables and activities, organized over 4 key areas, had been mostly accomplished and presented a detailed account of these in the 2018 BAP Activity Summary of Accomplishments (fda.gov).
The updated 2024 Biosimilars Action Plan presented in a web-based format, is organized by overarching “Goals” and targeted “Aims” that outline the FDA’s “continued efforts to encourage innovation and competition for biologics and to facilitate the development and approval of high quality, safe, and effective biosimilar and interchangeable biosimilar products for the American public”. The four goals are clearly set-out in the graphic from the Plan reproduced below.
This fourth goal, to support the adoption of biosimilars, identify false or misleading statements about biosimilars and deter anticompetitive behaviors in the biological product marketplace, has seen the FDA work together with the Federal Trade Commission (FTC).
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