The U.S. Food and Drug Administration (FDA) and the E.U. European Medicines Agency (EMA) announced that Slovakia has beeen added to a...
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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What Pharma Companies Must Do Globally to Benefit From Canada’s Patent Term Extension Framework
By Aydin Harston and AJ Teigen Comments are off
Canada implemented its patent term extension program, the Certificate of Supplementary Protection (CSP) framework, on September 21, 2017....
Tagged with: Canada, CSP Framework, Featured, Medicinal
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By Benjamin R. Holt Comments are off
On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by...
Tagged with: aBLA, Amgen, BPCIA, Enbrel®, etanercept, Eticovo, FDA, Featured, Patent Dance, Regulatory, Samsung Bioepis, Sandoz
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By Aydin Harston Comments are off
FDA approves the second Enbrel® (etanercept) biosimilar—no etanercept biosimilar has launched in the United States to date.FDA approves...
Tagged with: BPCIA, EMA, FDA, Featured, Regulatory
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By Monica Chin Kitts Comments are off
Many factors contribute to the price that consumers pay for prescription drugs and biologics. These factors include research and...
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By Aydin Harston Comments are off
Coherus launches UdenycaTM, a pegfilgrastim biosimilar, in the United States. Pfizer launches Retacrit®, an epoetin alfa...
Tagged with: BPCIA, EMA, FDA, Featured, Regulatory
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By Aydin Harston Comments are off
European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar Pfizer launches NivestymTM,...
Tagged with: BPCIA, EMA, FDA, Featured, Regulatory
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