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Fish Attorneys Author Biosimilar Development Article, “Regulatory And Legislative Actions Set The Tone For Biosimilars In 2021”

Fish & Richardson Trademark & Copyright Thoughts

In particular, the authors review FDA’s preparation for the March 23, 2020 transition date, as well as FDA’s efforts to address biosimilar competition, interchangeability, and the COVID-19 pandemic. As of FY 2020 Q4, there were 84 biosimilar development programs enrolled in the biosimilar biological product development (BPD) program.

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Biosimilars 2020 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

The biosimilar pathway was designed to increase competition for biologics and reduce healthcare costs. At the same time, market uptake of biosimilars in the United States continued to increase, suggesting that there is room for expansion of biosimilars in the U.S. Legislation Relating to Biologics and Biosimilars.