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.

Genentech Moves for Temporary Restraining Order and Preliminary Injunction Against Amgen

Last night, Genentech filed a motion for a temporary restraining order and a motion for a preliminary injunction against Amgen in the Genentech v. Amgen BPCIA litigation related to Amgen’s trastuzumab biosimilar KANJINTI (trastuzumab-anns).  Genentech’s motion papers were filed under seal, and Amgen’s responsive papers on the preliminary injunction motion…

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Biosimilar and Follow-On Biologic Development Updates

Below are some highlights of recent news in biosimilar and follow-on biologic development: Prestige BioPharma On July 2, Prestige BioPharma (Prestige) licensed the rights to Tuznue, its trastuzumab biosimilar of Roche’s Herceptin, to Mundipharma in selected European markets. The European Medicines Agency (EMA) recently accepted a Marketing Authorisation Application for…

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Samsung Bioepis and Genentech Settle Trastuzumab Biosimilar Patent Disputes

On June 28, 2019, Samsung Bioepis and Genentech filed a joint stipulation of dismissal of their BPCIA patent litigation concerning ONTRUZANT (trastuzumab-dttb), Samsung Bioepis’s biosimilar of HERCEPTIN that received FDA-approval earlier this year.  According to the stipulation, the parties “have entered into a settlement agreement, and mutually agree to voluntarily dismiss…

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AbbVie to Acquire Allergan for $63B

U.S.-based AbbVie, Inc. has reached a deal to acquire Irish pharmaceutical company Allergan PLC for about $63 billion, according to an AbbVie press release from Tuesday.  The “definitive transaction agreement” includes both cash and stock.  According to the press release, it is expected that, immediately after the closing of the…

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Amgen petitions for rehearing en banc following Federal Circuit decision

On June 7, 2019, Amgen filed a petition for rehearing en banc of the Federal Circuit’s recent affirmance of summary judgment of non-infringement in favor of Sandoz in the BPCIA litigation regarding Sandoz’s ZARXIO (filgrastim-sndz) biosimilar and pegfilgrastim biosimilar candidate.  As we previously reported, on May 8, 2019, a Federal…

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