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Biosimilars 2021 Year in Review | Fish & Richardson

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology. ....

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Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021 | Goodwin

As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year. President Biden Signs Orange Book Transparency Act - . ....

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FDA Issues Revised Guidance on Biosimilar Development and BPCIA | Goodwin

On September 20, 2021, the FDA issued a revised final guidance for industry entitled “Questions and Answers on Biosimilar Development and the BPCI Act” and a third revision to its draft. ....

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