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  • Posted in:

    • Legal

    Briefing Completed in Supreme Court’s First Biosimilar Case

    By Nicole DeAbrantes April 14, 2017 Comments are off

    As we previously reported in this post, the Supreme Court granted certiorari in its first biosimilar case on Sandoz’s petition in Sandoz,...

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    Tagged with: Amgen v. Sandoz, BPCIA, Legal, Litigation, Notice Requirement, Patent Dance, Sandoz v. Amgen, Supreme Court

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  • Posted in:

    • Legal

    Complaint in Genentech v. Amgen Dismissed Without Prejudice

    By Daniel McCallum and C. Nichole Gifford March 2, 2017 Comments are off

    Genentech’s lawsuit against Amgen has come to a quick (although perhaps temporary) end, with the Court dismissing Genentech’s complaint...

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    Tagged with: Amgen, Avastin®, bevacizumab, BPCIA, District Court, Genentech, Genentech v. Amgen, Legal, Litigation, Patent Dance

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  • Posted in:

    • Legal

    Genentech Sues Amgen Over BPCIA Disclosures for Avastin® (bevacizumab)

    By C. Nichole Gifford February 20, 2017 Comments are off

    On February 15, 2017, Genentech filed litigation accusing Amgen of violating the Biologics Price Competition and Innovation Act...

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    Tagged with: Avastin®, bevacizumab, BPCIA, District Court, Genentech v. Amgen, Legal, Litigation, Patent Dance

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  • Posted in:

    • Legal

    Supreme Court Grants Certiorari in First Biosimilar Case

    By Nicole DeAbrantes and C. Nichole Gifford January 26, 2017 Comments are off

    The Supreme Court has agreed to hear its first biosimilar case interpreting two provisions of the Biologics Price Competition and...

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    Tagged with: Amgen v. Sandoz, BPCIA, Legal, Litigation, Notice Requirement, Patent Dance, Sandoz v. Amgen, Supreme Court

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  • Posted in:

    • Regulatory

    FDA Issues Draft Guidance on Demonstrating Interchangeability

    By Seth Cockrum January 20, 2017 Comments are off

    Introduction The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological...

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    Tagged with: BPCIA, FDA, Featured, Guidance, Interchangeability, Labeling, Regulatory

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