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Biosimilars Action Plan (BAP) Pharmaceutical Patents

Goodwin

Comments and Letters to FDA in Response to Biosimilars Action Plan

Goodwin on

The Association for Accessible Medicines (AAM) and Biosimilars Council submitted comments to FDA two weeks ago regarding “the biosimilars action plan and ways to facilitate competition” in the biosimilars industry....more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for July 2018?

This month, we highlight significant developments from July 2018, including the FDA’s Biosimilar Action Plan for “reducing gaming of FDA requirements or other attempts to unfairly delay competition” and the much anticipated...more

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