Practice Area


FDA Announces Biosimilar Product Approval Developments

Information regarding how the FDA will process biosimilar product applications under the Approval Pathway for Biosimilar Biological Products (the Biosimilar Pathway), a component of the U.S. Patient Protection and Affordable Care Act, has been anxiously anticipated. The FDA’s comments on implementation of the U.S. Biosimilar Pathway, published today in the New England Journal of Medicine, indicate that the Administration will apply the “totality of the evidence” standard in determining if a biosimilar reference product is sufficiently similar to a sponsor product for approval. The authors, four physicians from the Administration, stated that additional animal and clinical studies will be needed, generally, for protein biosimilars and that even small changes could affect safety or efficacy. Regarding meeting the “interchangeability” standard, the Administration reports no progress but indicates, “the FDA will carefully consider what data will be necessary for this purpose…” Link to article.