Welcome to the Big Molecule Watch!


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.

Amgen and Kashiv Ask District Court to Dismiss Their Filgrastim Biosimilar Litigation

On November 22, 2019, the parties in the Amgen v. Kashiv BPCIA litigation, concerning Kashiv’s proposed biosimilar of NEUPOGEN (filgrastim), submitted a stipulation of dismissal indicating that they have “agree[d] to the dismissal, without prejudice, of all remaining claims and counterclaims in this action with the parties to bear their own…

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China NMPA Approves Adalimumab Biosimilar

On November 7, Bio-Thera Solutions, Ltd. announced that the China National Medical Products Administration (NMPA) approved QLETLI®, a biosimilar to AbbVie’s HUMIRA® (adalimumab). QLETLI® is the first adalimumab biosimilar approved by the NMPA and has been approved for the treatment of three autoimmune diseases, including rheumatoid arthritis, ankylosing spondylitis, and plaque…

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Big Conversations: In-House Counsel Discuss the Past, Present, and Future of Biosimilars Market Entry In the EU and U.S. (Part 4)

In a continuation from Part 3 of this panel discussion, Goodwin and Bristows continue their discussion with senior in-house counsel at the forefront of the biosimilars industry to discuss the pace of biosimilars market entry in the EU and U.S., why the pace of biosimilars market entry has been different…

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FDA Approves Sandoz's Biosimilar Pegfilgrastim

As we have previously reported on Sandoz’s Biologics License Application (“BLA”) for its proposed biosimilar to Neulasta® (pegfilgrastim), Sandoz received a complete response letter from FDA, and had resubmitted its application after reportedly addressing the issues identified by FDA.  Yesterday, the FDA approved Sandoz’s application.  The biosimilar, named ZIEXTENZO, is an injectable formulation of pegfilgrastim-bmez, with…

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Pfizer Announces U.S. Launch Dates for Three Biosimilars

Earlier this week, during its 3Q 2019 earnings call, Pfizer announced the U.S. launch dates for three of its biosimilar products: ZIRABEV (bevacizumab-bvzr), a biosimilar of Genentech’s AVASTIN, which received approval in June, will launch December 31, 2019.  We previously posted that on September 20, 2019, Genentech and Pfizer settled…

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