FDA Faces Challenges in Developing Biosimilars Pathway, Agency Officials Say

The Food and Drug Administration faces numerous challenges in developing a pathway for biosimilar drugs, officials from the agency said in an article published Aug. 3 in the New England Journal of Medicine.

The Patient Protection and Affordable Care Act (PPACA) created a legal framework for an abbreviated approval pathway for follow-on versions of biologic drugs (also known as biosimilars), charging FDA with the task of implementing that pathway. According to the article, “Developing the Nation’s Biosimilar Program,” reconciling the science of biosimilar development with the new regulatory framework presents numerous challenges for the agency. ...