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.

Amicus Briefs Filed in Amgen v. Sandoz

Hospira, Inc., Celltrion Healthcare Co., Ltd., and Celltrion Inc. (jointly) and the Biosimilars Council filed amicus briefs today in support of Sandoz’s petition for rehearing en banc in Amgen v. Sandoz.  The briefs are now publicly available and are attached here and here. UPDATE: Mylan Inc. has also filed an amicus…

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BREAKING NEWS--Sandoz launches biosimilar product Zarxio in the U.S.

Following the end of the injunction imposed by the Federal Circuit’s July 21st opinion in Amgen v. Sandoz, Sandoz today launched its biosimilar product Zarxio–the first product to be approved under the BPCIA’s abbreviated approval pathway for biosimilars.  Zarxio is a biosimilar product referencing Amgen’s Neupogen (filgrastim) product, and will be sold at…

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PTAB Seeks to Nip Abusive IPRs in the Bud

The PTAB is asking for briefing on whether IPRs filed by the Coalition for Affordable Drugs against Shire PLC should be dismissed for abuse of the IPR process. The petitions (Nos. IPR2015-00990 and IPR2015-01093) concern U.S. Patent No. 7,056,886, directed to GLP-2 peptides and analogs thereof, which may be used…

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BREAKING NEWS--Federal Circuit Denies Amgen's Emergency Motion for a Temporary Injunction in Amgen v. Sandoz

The Federal Circuit has denied Amgen’s Emergency motion for a temporary injunction pending en banc consideration and review in Amgen v. Sandoz.  Per the Federal Circuit’s July 21st decision, Sandoz was enjoined from marketing its biosimilar filgrastim product, Zarxio, until 180 days from the date it received FDA approval for its product.  That original injunction…

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BREAKING NEWS – Amgen v. Sandoz:  Sandoz’s Response to Amgen’s Emergency Motion for an Injunction Pending En Banc Consideration and Review

Sandoz has filed its opposition to Amgen’s motion seeking an “emergency”  injunction from the Federal Circuit to extend the injunction blocking Sandoz from launching its Zarxio biosimilar past September 2, the date the injunction is currently set to expire.  In its opposition, Sandoz blasts Amgen’s motion as “perfunctory” and not meeting…

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BREAKING NEWS—Amgen v. Sandoz: Amgen’s Emergency Motion for an Injunction Pending En Banc Consideration and Review

Following the parties’ petitions for rehearing en banc in Amgen v. Sandoz, Amgen has filed an emergency motion for an injunction to block the launch of Sandoz’s FDA-approved biosimilar filgrastim product, pending the Federal Circuit’s en banc consideration and review.  Sandoz is currently enjoined from marketing its biosimilar product, Zarxio,…

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Update in Amgen v. Apotex: Scheduling Report

As we reported in an earlier post, Amgen v. Apotex is the first biosimilar litigation in which the parties have actually danced the entire “patent dance” through the “first wave.” The case, which concerns Apotex’s application to market a biosimilar version of Neulasta, has already been scheduled for trial beginning July…

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IPR Tracker: IPR2015-01792 (Coalition for Affordable Drugs V LLC, et al.) (U.S. Patent No. 8,163,522)

  IPR2015-01792 (Coalition for Affordable Drugs V LLC, et al.) (U.S. Patent No. 8,163,522) Petitioners: Coalition for Affordable Drugs V LLC; Erich Spangenberg; Hayman Capital Management, LP; Hayman Captial Master Fund, LP; Hayman Credes Master Fund, LP; Hayman Investments, LLC; Hayman Offshore Management, Inc.; Hayman Orange Fund SPC – Portfolio…

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