According to a new report by RAND Corporation, biosimilars could save $54 billion in healthcare spending on biologics over the next ten...
BPCIA
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Update: How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline
By Andrew Storaska and Aydin Harston Comments are off
European Medicines Agency newly approves five rituximab biosimilars and an etanercept biosimilar, while recommending approval of...
Tagged with: BPCIA, EMA, FDA, Regulatory
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By C. Nichole Gifford Comments are off
Recently, AbbVie, Inc. and AbbVie Biotechnology, LTD (collectively “AbbVie” or “Plaintiffs”) filed a Complaint in the United States...
Tagged with: AbbVie, adalimumab, Boehringer Ingelheim, BPCIA, District Court, Humira®, Legal, Litigation, Patent Dance
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By Aydin Harston Comments are off
The U.S. Senate passed S.934 – FDA Reauthorization Act of 2017 on Thursday, August 3, 2017, by a 94-1 vote after having been passed by...
Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory
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By Spencer Johnson Comments are off
Since our prior article on the litigation between Amgen and Hospira over Hospira’s proposed biosimilar to Amgen’s Epogen®, there have...
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The Supreme Court’s Decision in Amgen v. Sandoz: Clear Guidance and Open Questions for Biosimilars
By Jennifer P. Nock Comments are off
As we previously reported here, earlier this year the Supreme Court agreed to hear its first case arising under the Biosimilars Price...
Tagged with: Amgen v. Sandoz, BPCIA, Legal, Litigation, Notice Requirement, Patent Dance, Sandoz v. Amgen, Supreme Court
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By Aydin Harston and Andrew Storaska Comments are off
H.R.2430 – FDA Reauthorization Act of 2017, a bill reauthorizing all of the U.S. Food and Drug Administration (“FDA”) user fee...
Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory
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By Nicole DeAbrantes Comments are off
The patent venue statue, 28 U.S.C. § 1400(b), states that “ny civil action for patent infringement may be brought in the judicial...
Tagged with: BPCIA, District Court, Federal Court, Legal, Litigation, News, Supreme Court, Venue
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By Aydin Harston Comments are off
The Biosimilar User Fee Act (“BsUFA”) was originally enacted in 2012, and the current legislative authority is set to expire at the end...
Tagged with: BPCIA, BSUFA II, FDA, Guidance, Regulatory
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