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.

National Comprehensive Cancer Network (NCCN) Issues New Set of Guidelines For Biosimilar Use

This month, a working group within the Pharmacy Directors Forum of the National Comprehensive Cancer Network (NCCN) has reviewed and highlighted “some of the potential challenges regarding adopting biosimilars into clinical practice,” making “several recommendations for the safe and efficient use of biosimilar medications in the clinical setting.” The group…

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Women’s History Month: Janet Woodcock

In honor of Women’s History Month, Big Molecule Watch will highlight the work of women who have contributed to the advancement of biologics and biosimilars. One such individual is Janet Woodcock, current acting Commissioner of the U.S. Food and Drug Administration (FDA) and director for Drug Evaluation and Research, who has held a number…

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7th Circuit Evaluates the "Patent Thicket"

Last week the 7th Circuit Court of Appeals heard arguments in UFCW Local 1500 Welfare Fund v. AbbVie Inc., Case No. 20-2402.  The appeal concerns the United States District Court for the Northern District of Illinois’ dismissal of a proposed class action alleging that AbbVie, Inc. created a “patent thicket”…

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Formycon and Biocon Biologics/Viatris Share Recent Biosimilars Development News

On March 1, 2021, Formycon announced that it plans to resubmit its BLA for its Lucentis® Biosimilar Candidate FBY201 (ranibizumab) in the first half of 2021.  Formycon expects to submit its application to the EMA soon thereafter, and will also seek approval in Canada, Australia, the United Kingdom and Switzerland….

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Minnesota Bill Aimed at Expanding Access to Biosimilars

Last Wednesday, State Senator Carla Nelson and State Representative Jennifer Schulz of Minnesota announced the introduction of a bill aimed at reducing the price of certain medications by expanding access to biosimilars.  The bill requires that pharmacy benefit managers and health carriers must not require or demonstrate a preference to…

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