Generic Industry Wants US FDA To Consider Allowing Foreign Reference Products For ANDAs
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.
You may also be interested in...
Meeting management and some application assessment changes also may be necessary as stakeholders prepare for the second biosimilar user fee program reauthorization.
The idea could help quiet growing criticism over system gaming and high drug prices.
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.