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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FDA approves the second Enbrel® (etanercept) biosimilar—no etanercept biosimilar has launched in the United States to date.FDA approves...
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On March 7, 2019, the U.S. Food & Drug Administration (FDA) released updated draft guidance announcing that it will create special...
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Coherus launches UdenycaTM, a pegfilgrastim biosimilar, in the United States. Pfizer launches Retacrit®, an epoetin alfa...
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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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European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar Pfizer launches NivestymTM,...
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FDA approves first Neulasta® (pegfilgrastim) and Procrit® (epoetin alfa) biosimilars and second Neupogen® (filgrastim biosimilar)...
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European Medicines Agency approves second trastuzumab and third insulin glargine biosimilars FDA has not approved any biosimilar...
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Biologic drugs are large molecules, such as therapeutic proteins, DNA vaccines, monoclonal antibodies, and fusion proteins, that are...