The U.S. Food and Drug Administration (FDA) and the E.U. European Medicines Agency (EMA) announced that Slovakia has beeen added to a...
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On July 11, 2019, more than 110 House Democrats wrote a letter to U.S. Trade Representative Robert E. Lighthizer expressing strong...
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Canada implemented its patent term extension program, the Certificate of Supplementary Protection (CSP) framework, on September 21, 2017....
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In a recent precedential opinion, the Federal Circuit rejected arguments by Amgen that a single step purification process used by Sandoz...
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On May 20, 2019, the PTAB denied a request for rehearing in Apotex Inc. v. Amgen Inc., Case IPR2016-01542 (Paper 67), but modified its...
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On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by...
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Recently, in Adello Biologics LLC v. Amgen Inc., Case PGR2019-00001 (Paper No. 13) (PTAB Apr. 19, 2019), the PTAB instituted...
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FDA approves the second Enbrel® (etanercept) biosimilar—no etanercept biosimilar has launched in the United States to date.FDA approves...
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Coherus launches UdenycaTM, a pegfilgrastim biosimilar, in the United States. Pfizer launches Retacrit®, an epoetin alfa...
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