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.

Apotex Moves to Expedite Briefing on Appeal in Amgen v. Apotex

As we covered last week (here), Apotex is appealing the district court’s grant of a preliminary injunction to Amgen in Amgen v. Apotex. Apotex has now moved to expedite the briefing schedule on its appeal in the Federal Circuit.  In its motion, Apotex explains: “Under the district court’s order, Apotex suffers immediate harm because the launch…

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Korea Approves Biosimilar of Remicade

On December 7 Samsung Bioepis and Merck announced that Samsung Bioepis had received approval for its RENFLEXIS product by the Ministry of Food and Drug Safety in Korea. RENFLEXIS, a biosimilar version of Janssen Biotech’s Remicade (infliximab), was approved for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative…

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UPDATED: Amgen Hoping to Capitalize on Preliminary Injunction Win in Florida in Other Litigation

After winning a preliminary injunction in Amgen v. Apotex, Amgen now hopes to capitalize on that win in another pending BPCIA case, Amgen v. Hospira, which is being litigated in the District of Delaware. Amgen filed a notice of supplemental authority in the Hospira case citing the Florida District Court’s order in Apotex in an attempt to provide further support for…

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