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Posts tagged J&J
Is J&J's Remicade® part of the "rigged" system claimed by FDA's Gottlieb? Pfizer's Inflectra® antitrust suit has the answer.

FDA’s Commissioner Scott Gottlieb said today that a “rigged” system between drug firms and insurers is stifling entry for less-expensive biosimilars.  Gottlieb stated that certain payment arrangements “raise another, perhaps even more insidious barrier to biosimilars taking root in the U.S., and gaining appropriate market share.”  Is J&J’s exclusionary contract scheme to discourage competition with Pfizer’s biosimilar for Remicade® a poster child for what Gottlieb is lamenting?  Pfizer recently sued Janssen over that very question, and the federal court is scheduled to decide a motion answering that question very shortly. 

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When do biosimilars launch at risk?

The biosimilar statute, Biologics Price Competition and Innovation Act (BPCIA, was passed in 2010.  Since then, drug companies have been filing biosimilar applications with FDA.  And even though, FDA has approved only nine biosimilar drugs today, an interesting trend may be emerging: biosimilars may be more willing to launch at-risk than small-molecule generics.

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