As we recently covered, May 15, 2018, saw the FDA granting approval to Hospira (now a Pfizer subsidiary) for its Retacrit injection, a...
Epogen®
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By Seth Cockrum Comments are off
Today, the FDA announced that it approved Retacrit (epoetin alfa-epbx) as a biosimilar to Epogen® for the treatment of anemia caused by...
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By Spencer Johnson Comments are off
Since our prior article on the litigation between Amgen and Hospira over Hospira’s proposed biosimilar to Amgen’s Epogen®, there have...
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By C. Nichole Gifford Comments are off
We previously reported that after a public meeting held on May 25, 2017, the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended...
Tagged with: Amgen, epoetin alfa, Epogen®, FDA, Hospira, News, Pfizer, Regulatory
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By Spencer Johnson Comments are off
Introduction The Amgen, Inc. and Amgen Manufacturing, Limited (“Amgen”) litigation against Hospira, Inc. (“Hospira”), filed in...
Tagged with: Amgen, Amgen v. Hospira, BPCIA, District Court, epoetin alfa, Epogen®, Erythropoietin, Featured, Federal Circuit, Hospira, Janssen, Legal, Litigation, Notice Requirement, Patent Dance, Pfizer, Procrit®, Retacrit®, Supreme Court
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By C. Nichole Gifford Comments are off
Pfizer announced last week that the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended its proposed biosimilar to Amgen’s...
Tagged with: Amgen, Amgen v. Hospira, BPCIA, epoetin alfa, Epogen®, FDA, Hospira, Janssen, News, Pfizer, Procrit®, Regulatory, Retacrit®
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