Washington, DC (Mar. 27)—US Representatives Anna G. Eshoo (D-CA) and Joe Barton (R-TX) introduced legislation this month week to create a regulatory pathway for biosimilars, or follow-on biologics. The so-called Pathway for Biosimilars Act would allow the US Food and Drug Administration to determine “whether the biosimilar is interchangeable with the reference product, and gives the FDA the flexibility to determine what clinical testing—if any—is required for approval,” according to a release from Rep. Eschoo.

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Pharmaceutical Technology