Tagged as: Biosimilars News

BREAKING NEWS: Federal Circuit Rejects Genentech’s Bid to Block Sales of Amgen’s Trastuzumab Biosimilar

Following the oral argument three days ago, the U.S. Court of Appeals for the Federal Circuit today affirmed the lower court’s denial of Genentech’s motion for a preliminary injunction to enjoin sales of Amgen’s KANJINTI (trastuzumab-anns) biosimilar product. As we previously reported, Amgen launched KANJINTI in the United States in…

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Biosimilar Developers Comment on Regulatory Delays

Multiple biosimilar developers recently released statements regarding potential regulatory delays facing their biosimilars or follow-on biologics. Insulin As we previously reported, Biocon and Mylan are collaborating in the development of a follow-on product to Sanofi’s LANTUS (insulin glargine). On February 22, 2020, Biocon announced that the U.S. FDA had conducted…

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BREAKING NEWS: Celltrion Prevails Over Janssen in Infliximab Biosimilar Appeal

Today, the Federal Circuit issued a Rule 36 affirmance of the district court’s judgment of non-infringement in the litigation involving Celltrion’s infliximab biosimilar.  The court heard oral argument in the appeal yesterday.  As we previously reported, Janssen had appealed the district court’s order granting Celltrion’s motion for summary judgment of non-infringement of…

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Federal Circuit Hears Argument Regarding the Denial of Genentech’s Motion to Preliminarily Enjoin Amgen’s Sales of Trastuzumab

We previously reported on Genentech’s appeal of the district court’s denial of Genentech’s motion for a preliminary injunction against Amgen’s launch of trastuzumab. Yesterday, a Federal Circuit panel (Judges Prost, Wallach, and Bryson) heard argument regarding on Genentech’s appeal. The argument, much like the appellate briefing, focused on the issue…

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FDA Issues Draft Guidance On Biosimilar Licensure For Fewer Than All Conditions Licensed for Reference Product

The FDA issued a draft guidance today titled “Biosimilars and Interchangeable Biosimilars: Licensure for Fewer Than All Conditions of Use for Which the Reference Product Has Been Licensed.”  In this guidance, the FDA addresses the following issues: Submission of an application seeking licensure of a proposed biosimilar or proposed interchangeable…

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FDA’s Draft Guidance on Promotional Labeling and Advertising Considerations

Earlier this week FDA issued a draft guidance on “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products.” The draft guidance addresses the truthful and non-misleading manner in which data and information concerning reference or biosimilar products must be presented. The draft guidance does not address issues…

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