After almost no movement in the last year on the biosimilar regulatory front, the Food and Drug Administration (FDA) and the White House both have weighed in this past week, proposing significant changes and implementation guidelines for this important regulatory pathway. The new guidelines outline the process through which the FDA will approve biologics based on the demonstration that they are biosimilar to, or interchangeable with, already approved reference biological products. Although far from perfect, these guidelines will help biosimilar manufacturers meet rapidly expanding patient needs and open the door to less expensive versions of approved biological products, which accounted for $138 billion in U.S. sales in 2010 alone.

Biosimilars include a large variety of biological products, including vaccines, blood and blood components, gene therapies, tissues, and proteins (such as antibodies). In contrast to producers of traditional chemical-based therapies, manufacturers of biological products face greater technical barriers-to-entry as a result of more complicated manufacturing processes. The three guidance documents issued by the FDA on February 9, 2012, reflect the agency's attempt to assist applicants seeking approval through the abbreviated biosimilar pathway (or 351(k) application) set forth in the Biologics Price Competition and Innovation Act (BPCI). The FDA will formally publish the guideline documents in the Federal Register, at which point the public will be invited to comment within 60 days.

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