As we previously reported in this post, the Supreme Court granted certiorari in its first biosimilar case on Sandoz’s petition in Sandoz,...
BPCIA
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By Daniel McCallum and C. Nichole Gifford Comments are off
Genentech’s lawsuit against Amgen has come to a quick (although perhaps temporary) end, with the Court dismissing Genentech’s complaint...
Tagged with: Amgen, Avastin®, bevacizumab, BPCIA, District Court, Genentech, Genentech v. Amgen, Legal, Litigation, Patent Dance
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By C. Nichole Gifford Comments are off
On February 15, 2017, Genentech filed litigation accusing Amgen of violating the Biologics Price Competition and Innovation Act...
Tagged with: Avastin®, bevacizumab, BPCIA, District Court, Genentech v. Amgen, Legal, Litigation, Patent Dance
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By Nicole DeAbrantes and C. Nichole Gifford Comments are off
The Supreme Court has agreed to hear its first biosimilar case interpreting two provisions of the Biologics Price Competition and...
Tagged with: Amgen v. Sandoz, BPCIA, Legal, Litigation, Notice Requirement, Patent Dance, Sandoz v. Amgen, Supreme Court
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By Seth Cockrum Comments are off
Introduction The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological...
Tagged with: BPCIA, FDA, Featured, Guidance, Interchangeability, Labeling, Regulatory
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