Bill introduced to Senate for Biosimilars

On March 26, the bill “Promoting Innovation and Access to Life-Saving Medicine Act'”was introduced by Senators Charles Schumer (D-NY), Sherrod Brown (D-OH), Susan Collins (R-ME), Mel Martinez (R-FL). The goal of this bill is to establish regulatory routes for biosimilars.

A key provision in the Senate bill is to establish five years of market exclusivity for a biologic product from the time the brand-name drug was approved. The bill also establishes a procedure for resolution of patent disputes before a biosimilar is approved and establishes penalties for failure to litigate patents in a timely fashion.

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