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Biosimilars 2020 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

For the first time since FDA licensed the first biosimilar, Sandoz’s Zarxio ® (filgrastim-sndz), in 2015, the United States saw a decrease in annual biosimilar approvals in 2020. Legislation Relating to Biologics and Biosimilars. BPCIA Litigation. Antitrust Litigation. Post-Grant Challenges at the PTAB. Conclusion.