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

By Dr. David Shoemaker, Senior Vice President, R&D

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. The BPCIA was intended to be a major cost-containment mechanism of the Patient Protection and Affordable Care Act of 2010. The origin of the BPCIA had its roots in the Drug Price Competition and Patent Restoration Act of 1984 championed by Senators Waxman and Hatch, which has provided low-cost generic alternatives to prescription brand-name drugs for the three subsequent decades. What Congress failed to appreciate at the time was the current state of protein characterization science and consequently whether interchangeability could in fact be obtained or what level of biosimilarity was acceptable.