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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BiosimilarsIP.com Regulatory provides articles about regulatory issues and events related to biologics and biosimilars from the FDA, the EMA and other international agencies.
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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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On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by...
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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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Many factors contribute to the price that consumers pay for prescription drugs and biologics. These factors include research and...
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Coherus launches UdenycaTM, a pegfilgrastim biosimilar, in the United States. Pfizer launches Retacrit®, an epoetin alfa...
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European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar Pfizer launches NivestymTM,...
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