About three years ago, and less than two years after Congress passed and President Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law, the U.S. Food and Drug Administration issued a series of draft Guidances indicating how it was considering implementing the biosimilar approval pathway contained in the Act. The Guidances (see "FDA Publishes Draft Guidelines for Biosimilar Product Development" and "More on FDA Draft Guidelines for "Follow-on" Biologic Drug Approval Pathway") were expressly "draft" in nature, and were the subject of public hearings and the Agency welcoming industry input. This input was necessary; even a cursory review of the pathway provisions of the law would be struck with the frequency with which Congress delegated to the FDA the details of setting out the requirements for biosimilar approval. This did not come as a shock, it being rational that Congress should recognize that Agency expertise was particularly important in developing standards for approving drugs as complex as biosimilars under circumstances where the "follow-on biologic" drugs were frankly not identical to the approved reference biologic product.
In April the Agency released "final" Guidances that look remarkably like the originals; these Guidances are entitled:
• Scientific Considerations in Demonstrating Biosimilarity to a Reference Product [link]
• Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product [link]
• Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009 [link]
The FDA has released an additional, more explicit Guidance related to the requirements for establishing biosimilarity since promulgating these first three (see "FDA Releases Draft Guidance on Biosimilars: Sets Forth Clinical, Pharmacology Data Sufficient to Support Biosimilarity") as well as a Guidance on market exclusivity (see "FDA Releases Another Prospective Guidance"). More importantly, the Agency recently approved the first biosimilar drug in the U.S. (see "FDA Approves Sandoz Filgrastim Biosimilar"). But as noted in the letter from several Senators discussed yesterday (see "Senators Send Letter on Biosimilars to FDA"), this progress has not come fast enough for some. In addition, the Agency has made at least one no-decision decision (using an "interim" non-proprietary name for Sandoz XARZIOTM product (filgastrim–sndz)) and has not yet addressed the standards for interchangeability. Which seems unfairly critical from the institution that left it to the Agency to actually develop a biosimilars pathway and, of course, be ready to take the blame for any problems arising along the way.
