In a 104-page ruling, U.S. District Judge Mark L. Wolf granted summary judgment in favor of Celltrion and Hospira, finding that a doctrine...
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Hospira
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As we recently covered, May 15, 2018, saw the FDA granting approval to Hospira (now a Pfizer subsidiary) for its Retacrit injection, a...
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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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This is our second update on the litigation (you can see the prior analyses here and here, in addition to a parallel post on our companion...
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As previously reported, earlier this year Celltrion, Inc. (“Celltrion”) filed petitions seeking inter partes review (“IPR”) of...
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Amgen and Allergan recently announced that they submitted a Biologics License Application (“BLA”) for ABP 980, a proposed biosimilar to...
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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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On June 30, 2017, Pfizer, Inc. (“Pfizer”) filed two new petitions for inter partes review (“IPR”) of U.S. Patent No. 8,591,897...
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We previously reported that after a public meeting held on May 25, 2017, the FDA’s Oncologic Drug Advisory Committee (ODAC) recommended...
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