Pay-for-Delay Bill Aimed At Blocking Brand/Generic Deals Gets Lower-Than-Expected Savings Estimate
CREATES Act and 180-day exclusivity reforms also in legislation headed to US House floor, even as generic industry remains opposed to two of the three main provisions. The Rx pricing language is bundled with Obamacare language designed to force a tough vote by Republicans.
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If agency adopts policy, it might obviate the need for the CREATES Act. Biosimilars already enjoy a degree flexibility of on the source of reference material that generic sponsors want extended to the less complicated small molecule drugs.
But even with the legislative and regulatory changes proposed by the Biosimilars Forum, market share would still not reach levels seen in Europe, an analysis by Avalere finds.
Only one of 232 brand-generic patent suit settlements in the US during FY 2016 contained a side deal or commitment not to market an authorized generic.