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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BPCIA
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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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The Biologics Price Competition and Innovation Act (“BPCIA”) requires applications to market a biological product be submitted for...
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Last month, the FDA released four new guidance documents providing insight on the FDA’s interpretation of provisions of the Biologics...
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The FDA recently proposed an amendment to its regulations defining the term “biological product.” The proposed amendment...
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On November 5, 2018, twenty-nine organizations representing various groups including insurance companies, patient and consumer advocacy...
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