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Biosimilar barriers

How a showdown over contracting practices could unleash the U.S. biosimilars market

A coming showdown over anticompetitive contracting practices, coupled with an impending wave of patent expirations, could result in a wave of biosimilar approvals and launches in the U.S. over the next year, according to biosimilars executives.

So far, IP issues have kept U.S. launches to a trickle. Since the Biologics Price Competition and Innovation (BPCI) Act of 2009 created the regulatory pathway for biosimilars, FDA has approved 12 products. Only four have launched, while seven are waiting for the expiration of exclusivity for reference products or are the subject of legal disputes about when they can enter the market.

Pfizer Inc.’s Nivestym filgrastim-aafi, a biosimilar of Amgen Inc.’s Neupogen filgrastim, was just approved July 20. The pharma declined to say when the product will launch.

Sluggish entry of U.S. biosimilars has translated into less cost savings from competition than originally expected. In 2009, the Congressional Budget Office (CBO) estimated that competition from biosimilars would save $5.9 billion in U.S. federal healthcare spending over the first 10 years, with about $3 billion of savings for Medicare Part B. An Avalere Health report published in May found the actual savings for Medicare Part B through 2017 were about $241 million, roughly 8% of the estimate.

Three companies who spoke to BioCentury

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