According to a new report by RAND Corporation, biosimilars could save $54 billion in healthcare spending on biologics over the next ten...
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BPCIA
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European Medicines Agency newly approves five rituximab biosimilars and an etanercept biosimilar, while recommending approval of...
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Recently, AbbVie, Inc. and AbbVie Biotechnology, LTD (collectively “AbbVie” or “Plaintiffs”) filed a Complaint in the United States...
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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...
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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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As we previously reported here, earlier this year the Supreme Court agreed to hear its first case arising under the Biosimilars Price...
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H.R.2430 – FDA Reauthorization Act of 2017, a bill reauthorizing all of the U.S. Food and Drug Administration (“FDA”) user fee...
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The patent venue statue, 28 U.S.C. § 1400(b), states that “ny civil action for patent infringement may be brought in the judicial...
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The Biosimilar User Fee Act (“BsUFA”) was originally enacted in 2012, and the current legislative authority is set to expire at the end...
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