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The US Biosimilar Approval Pathway:
Policy Precedes Science – A Regulatory Perspective

With the passage of the Biosimilar Price Competition and Innovation Act (BPCIA) in 2009, the US created new pathways for development and approval of biosimilar and interchangeable products (Section 351(k) of the Public Health Service (PHS) Act (42 U.S.C. 262)), in the hopes of creating a low-cost alternative to expensive, innovator-marketed biologics whose patent terms were expiring; however, only one biosimilar has been approved by the FDA to date.  

This article examines the reasons why the biosimilar pathway hasn't been utilized as much as expected, the anticipated use of this pathway in the immediate future, as well as the pathways product sponsors are choosing to pursue instead.

Dr. David ShoemakerDr. David Shoemaker, Senior Vice President, R&D has over 25 years of experience in research and pharmaceutical development. He has managed or contributed to dozens of INDs/CTAs and over a dozen successful NDAs, BLAs, and MAAs. Dr. Shoemaker has authored or overseen dozens of Orphan Drug Designation applications, has developed several successful Accelerated Approval programs, and has secured several Priority Review applications.