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Legal

The Federal Circuit Affirms District Court Finding that Sandoz Does Not Infringe Amgen’s Protein Purification Patent
By Andrew Storaska June 20, 2019 Comments are off
In a recent precedential opinion, the Federal Circuit rejected arguments by Amgen that a single step purification process used by Sandoz...

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Tagged with: aBLA, Amgen, Amgen v. Sandoz, doctrine of equivalents, FDA, Featured, Federal Circuit, Sandoz

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Posted in:
Regulatory

Another Biosimilar Receives FDA Approval and Is Confronted with Litigation
By Benjamin R. Holt June 4, 2019 Comments are off
On April 25, 2019, the U.S. Food and Drug Administration (“FDA”) approved new biosimilar product EticovoTM (etanercept-ykro) by...

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Tagged with: aBLA, Amgen, BPCIA, Enbrel®, etanercept, Eticovo, FDA, Featured, Patent Dance, Regulatory, Samsung Bioepis, Sandoz

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