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.

DEAL WATCH: Lupin and Mylan Announce Partnership to Commercialize Etanercept Biosimilar

Lupin Ltd. and Mylan N.V. both issued press releases today announcing a collaboration to commercialize a biosimilar to Amgen’s Enbrel® (etanercept).  Mylan will commercialize Lupin’s proposed etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia. According to the press releases, Lupin successfully completed its…

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FDA Announces Early Communications Program

The FDA’s Center for Biologics Evaluation and Research (CBER) is launching a new program called INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER ProducTs).  INTERACT meetings will replace pre-pre-IND meetings, but not formal product-specific meetings, such as pre-IND or pre-BLA meetings. According to the announcement, sponsors will be able to…

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Genentech Seeks to Dismiss and Strike Amgen's Counterclaims and Certain Defenses in Bevacizumab Biosimilar Litigation

As we previously reported, on May 22, 2018 in Genentech v. Amgen, which concerns Amgen’s Mvasi® (bevacizumab-awwb) biosimilar, Genentech filed a motion to dismiss and to strike Amgen’s counterclaims and certain affirmative defenses.  On June 19, 2018, after Amgen filed under seal an amended answer and counterclaim, Genentech filed updated…

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FDA Withdraws Draft Guidance Regarding Statistical Approaches to Evaluate Analytical Similarity of Biosimilars

As we previously reported, in September 2017 FDA issued draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity that “describes the type[s] of information a sponsor of a proposed biosimilar product should obtain” to support a showing of analytical similarity to a licensed reference product biologic.  Today, FDA withdrew this draft guidance….

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Vermont and Connecticut Enact Interchangeable Biosimilar Substitution Bills

Last month we reported that Vermont, Connecticut, New Hampshire, and Alaska were in the process of considering biosimilar substitution bills.  Vermont and Connecticut recently enacted their respective bills. On May 30, Vermont Governor Phil Scott signed bill S.92 into law as Act No. 193.  The Act directs pharmacists to dispense…

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