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.
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On September 15, Boehringer Ingelheim (BI) and Samsung Bioepis each issued a press release announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive […]
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As we
previously reported, Immunex
sued Sanofi and Regeneron earlier this year in the Central District of California alleging that the sale of Sanofi and Regeneron’s
FDA-approved Dupixent® (dupilumab) product would infringe […]
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The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights: On August 29, Pfizer filed two petitions for IPR of Genentech’s U.S. patents related to […]
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We
reported earlier this week that the district court in
Amgen v. Hospira denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit® (epoetin alfa) and granted-in-part and denied-in-part the parties’ respective motions for […]
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Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit
remand proceedings for
Amgen v. Sandoz, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s disclosure […]
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Goodwin’s
Intellectual Property and
Life Sciences teams won three awards, and were shortlisted in 10 categories for over 10 awards, at the 2017 LMG Life Sciences Awards hosted in New York City on […]
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As we previously
reported, last month AbbVie filed a
complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira (adalimumab) product. Yesterday, BI filed […]
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Today, the FDA
announced that it has approved Mvasi® (bevacizumab-awwb), Amgen’s biosimilar of Genentech’s Avastin®. According to the announcement, Mvasi® is the first biosimilar that the FDA has approved for the treatment of cancer. Mvasi® […]
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This morning, the district court in
Janssen v. Samsung Bioepis, which concerns Samsung Bioepis’
Renflexis® (infliximab-abda) biosimilar product, entered a
pretrial scheduling order. The scheduling order calls for, among other things, fact […]
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At the
European Society for Medical Oncology (“ESMO”) 2017 Congress, which was held over the past several days in Madrid, Spain, companies presented Phase 3 clinical data regarding two investigational biosimilars of Herceptin (trastuzumab). First, […]
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