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.

Amgen v. Sandoz: Reply Briefs Submitted to Supreme Court

As we previously reported, on February 16, 2016, Sandoz petitioned the United States Supreme Court for a writ of certiorari regarding the Federal Circuit’s interpretation of the BPCIA’s “notice of commercial marketing” provision—subsection (l)(8)(A)—as authorizing such notice only after FDA approval of an aBLA. In response, on March 21, Amgen…

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Halo Electronics, Inc. v. Pulse Electronics Inc.: the U.S. Supreme Court Establishes a New Framework for Awarding Enhanced Damages in Patent Suits

Yesterday, the Supreme Court announced its decision in Halo Electronics, decision in Halo Electronics, Inc. v Pulse Electronics, Inc., in which the Court rejected the Federal Circuit’s Seagate test and established a new framework for imposing enhanced damages for patent infringement.  Under the new framework, district courts will have greater…

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PTAB Institutes IPRs on Two More Humira Patents

Yesterday, the PTAB instituted IPRs on two of Abbvie’s Humira patents, U.S. Patent Nos. 9,017,680 and 9,073,987, which are drawn to dosing regimens for AbbVie’s Humira (adalimumab) for the treatment of rheumatoid arthritis. As previously reported here, the PTAB previously instituted an IPR on related U.S. Patent 8,889,135 based on a petition…

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Samsung Bioepis Presents New Biosimilars Data at EULAR 2016

At the Annual European Congress on Rheumatology (EULAR 2016), held last week in London, Samsung Bioepis presented new clinical data on its etanercept, adalimumab, and infliximab biosimilars.  According to a press release from Biogen, a partner in the Samsung Bioepis joint venture with Samsung BioLogics, Phase III studies for those anti-TNF-α biosimilars have demonstrated that…

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LG Life Sciences Begins Phase III Trials for Humira Biosimilar

LG Life Sciences recently announced the start of phase III clinical trials for its Humira® (adalimumab) biosimilar in South Korea.  The clinical trials will test the effectiveness of the biosimilar on rheumatoid arthritis patients who have shown negative responses to the chemotherapy drug methotrexate.  The trials will also compare the efficacy and safety…

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The Biosimilar Medicines Group Publishes New Guide

The Biosimilar Medicines Group recently published a new edition of their publication, Biosimilar Medicines Handbook, which provides a wealth of updated information on the current progress of biosimilar medicines in the European Union.  The first edition of this guide was published in 2007 when only five biosimilar medications had been…

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Amgen v. Hospira: Amgen Appeals Discovery Ruling

In the Amgen v. Hospira litigation, Amgen has filed a Notice of Appeal relating to Judge Andrew’s oral ruling denying Amgen’s request to compel Hospira to produce certain manufacturing information related to its Epogen® (epoetin alfa) biosimilar product.  We previously covered the discovery dispute in detail here. The appeal was placed on…

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