Advancing innovations in biosimilar product development; FDA report

Biologic products have revolutionized the treatment options for many diseases and typically carry favorable benefit–risk profiles compared with small molecule drugs.

Although these innovative products can enable longer lifespan and improved quality of life, the high cost of these products limits access, the US Food and Drug Administration noted. In the January 2023 themed issue of the FDA’s Clinical Pharmacology & Therapeutics on Innovations in Biosimilars, the opportunities to leverage innovations in clinical pharmacology and related disciplines to improve the efficiency of biosimilar development and approval are discussed, the US regulator stated.

Although there has been a steady stream of biosimilar approvals and launches in Europe, bringing down prices by as much as 80%, this has not been the case in the USA, where despite tentative approvals from the FDA, originators have fought off competition by legal actions.