Biosimilars (Generic Biotech Drugs) Receive FDA Guidelines for Accelerated Aproval/Competition Will Be Fierce

The Biologics Price Competition and Innovation Act of 2009 provided FDA guidelines for generic biotech drugs, which are called “biosimilars” or “follow-on biologics.” The Act establishes standards for FDA approval of biosimilars and details ways of handling patent disputes. The Act also grants 12 years of intellectual property protection to biologic drugs, which would significantly extend the life of branded biotech-based drugs. This exclusivity would protect the original maker of a biologic, because a generic competitor would not be able to utilize data from the clinical trials conducted by the original maker until the 12 years had passed and the original patent had also expired.

In February 2012, the FDA published guidelines that promised to speed the entry to the marketplace for generic versions of popular biotech drugs as they reach the end of their patent protection. Companies desiring to receive FDA approval to manufacture biosimilars now have a list of steps they must take. Most important to the speedy introduction of these generics is the fact that manufacturers are now allowed to rely to a large extent on the original clinical trials that were conducted by the manufacturers of the original drugs, despite the fact that the generics will likely be slightly different in biological makeup. Thanks to the guidelines, the FDA approved its first biosimilar in May 2015. Called Zarxio and produced by Sandoz International GmbH, the drug is a copy of Amgen Inc.’s Neupogen for the prevention of infections in patients receiving chemotherapy. However, Amgen immediately launched an extensive legal battle in an attempt to keep the generic off the market.

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