More than 650 generic drugs have been approved in the U.S. since FDA guidelines on generics approval were established in 1984. In stark contrast, not one company has gained approval for a biosimilar in the United States. Why? Because prior to February 2012, nobody knew how to do it.

A biosimilar is a biological product that has (1) highly similar clinically inactive components to the branded biologic it is trying to replace, and (2) no clinically meaningful differences in safety, purity, and potency. Like generics for small molecule agents, biosimilars are cheaper than their branded counterparts, potentially leading to an increase in market access for patients, and immense savings for healthcare systems, whether private or public.

The European Medicines Agency (EMA) became the first regulatory entity to establish biosimilar guidance (2005) and to approve a biosimilar (Omnitrope, 2006). Lagging significantly behind the EMA, the FDA belatedly gained the authority to approve biosimilars in 2010 through the Biologics Price Competition and Innovation Act, which was part of the Affordable Care Act signed by President Obama. However, this legislation only created the regulatory pathway by which a biosimilar could be approved, and did not provide any guidelines for prospective applicants to follow. It was not until February of 2012 that the FDA issued three draft guideline documents to help companies identify the best approach to the biosimilars approval process.

With these draft guidelines in place, we expect that the first FDA-approved biosimilars will arrive in 2014. And with six of the top 10 biologics (according to 2011 sales) losing patent protection by 2016, biosimilars will likely change the U.S. healthcare landscape in dramatic fashion. Although the FDA guidelines were issued more than 6 years after the EMA?s, given the impending biologics patent cliff, it looks like the guidelines were released just in time.

Gary Sing, Ph.D. is an Associate Consultant with the DRG Consulting group.

FDA Listing of Authorized Generics
FDA Biologics Price Competition and Innovation Act of the Public Health Service Act
Pharmaceuticals 2012, 5(12): 1393-1408.
Biosimilars Advisory Service, from BioTrends, a Decision Resources Group company

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