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.

The Ten-Year Anniversary of the Enactment of the BPCIA

Today, March 23, 2020, marks ten years since President Barack Obama signed the Biologics Price Competition and Innovation Act (BPCIA) into law as part of the Affordable Care Act.  The BPCIA—whose legislation certain members of the Big Molecule Watch team were involved in drafting—created an abbreviated regulatory pathway for seeking…

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COVID-19 Pandemic May Impact Biosimilars

The COVID-19 pandemic has introduced new challenges for the pharmaceutical industry, including makers of biosimilars.  In response, the FDA has asked pharmaceutical makers to closely monitor their supply chains and highlighted some of the ways the coronavirus could impact developmental pipelines. While the risk of supply chain disruptions is uncertain,…

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Biosimilars Development Updates: Mylan’s Pipeline, Coherus’s Adalimumab aBLA, Amgen’s Eculizumab Biosimilar

Mylan announced on its most recent quarterly earnings call that it expects to launch its rituximab and etanercept biosimilars in Europe later this year. In discussing Mylan’s biosimilars pipeline, Rajiv Malik, Mylan’s President, told market analysts, “we also have for Europe rituximab and Enbrel biosimilars, which will be most likely…

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Federal Circuit Denies Hospira’s Petition to Rehear Safe Harbor Ruling in Epoetin Biosimilar Dispute

The Federal Circuit has declined to reconsider its December 2019 affirmance of the district court ruling in the Amgen v. Hospira (epoetin alfa) dispute.  As we have previously reported, that ruling upheld a jury verdict finding (among other things) that Hospira’s manufacture of certain drug substance batches was not protected…

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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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