The U.S. Food and Drug Administration (FDA) and the E.U. European Medicines Agency (EMA) announced that Slovakia has beeen added to a...
FDA
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By Andrew Storaska Comments are off
In a recent precedential opinion, the Federal Circuit rejected arguments by Amgen that a single step purification process used by Sandoz...
Tagged with: aBLA, Amgen, Amgen v. Sandoz, doctrine of equivalents, FDA, Featured, Federal Circuit, Sandoz
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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 Benjamin R. Holt Comments are off
Over four years ago, in October 2014, Amgen initiated a patent infringement suit against Sanofi and Regeneron regarding biologics for...
Tagged with: Amgen, FDA, Federal Circuit, Praluent®, Regeneron, Repatha®, Sanofi, Supreme Court
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By Aydin Harston Comments are off
On March 7, 2019, the U.S. Food & Drug Administration (FDA) released updated draft guidance announcing that it will create special...
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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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FDA Issues Guidance Documents on the “Deemed to be a License” Transition Provision of the BPCIA
By Seth Cockrum Comments are off
The Biologics Price Competition and Innovation Act (“BPCIA”) requires applications to market a biological product be submitted for...
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