Welcome to the Big Molecule Watch!

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Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.

If you’re looking for a primer on biologics, check out our background post introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).

We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.

District Court of Delaware Construes “Following Fermentation” in Genentech v. Amgen Trastuzumab and Bevacizumab Cases

We have previously reported on the BPCIA Genentech v. Amgen cases relating to trastuzumab and bevacizumab. This week, Judge Connolly construed the term “following fermentation” as it relates to U.S. Patent No. 8,574,869 (“the Kao patent”) to mean “after the earlier of harvesting or purification has begun.” By way of…

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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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Amgen Responds to Hospira’s Motion For Rehearing En Banc of the Safe Harbor Ruling in the Epoetin Biosimilar Dispute

We previously reported that Hospira filed a petition for rehearing en banc of the Federal Circuit’s affirmance of a $70 million damages award to Amgen in the parties’ BPCIA litigation regarding Hospira’s RETACRIT (epoetin alfa-epbx), a biosimilar of EPOGEN. Last week, Amgen filed its response. As background, in December 2019,…

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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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