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So You Want To Make A Biosimilar: Top Considerations Before BLA Submission

LexBlog IP

Topics that will be covered include the 271(e) Safe Harbor, peremptory challenges, labelling and timing considerations, and competitive intelligence. Click here to register for the webinar.

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Biosimilars 2021 Year in Review

Fish & Richardson Trademark & Copyright Thoughts

The letter discusses the BPCIA and the Hatch-Waxman Act frameworks (for small molecule drugs) and sets forth several topics for USPTO’s consideration and further discussion: engagement between FDA and USPTO to increase efficiencies, possible misuse of the patent system (e.g., is a ‘submit[ter]’ of the aBLA within the meaning of 35 U.S.C. §