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.

FDA Approves First Rituximab Biosimilar

On Wednesday, the FDA approved the first biosimilar to Genentech’s RITUXAN®. The FDA’s press release noted that Teva and Celltrion’s biosimilar TRUXIMA® (rituximab-abbs) is the first biosimilar to be approved in the U.S. for the treatment of non-Hodgkin’s lymphoma. TRUXIMA® is indicated for treatment of adult patients for: Relapsed or…

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European Commission Approves Pegfilgrastim Biosimilars

The European Commission (EC) recently approved two biosimilars to Neulasta (pegfilgrastim). First, Mundipharma announced last week that the EC granted approval for Pelmeg▼®, a product it had acquired from biosimilar development company Cinfa Biotech.  According to Mundipharma, the product is approved for the “use of Pelmeg▼® as a treatment for…

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Biogen and Samsung BioLogics Close Asset Transfer Deal

As we previously reported, Biogen has exercised its option to purchase additional shares of Samsung Bioepis, increasing Biogen’s ownership in the Samsung Bioepis joint venture from approximately 5.4% to approximately 49.9%.  Last week, Samsung BioLogics announced that the asset transfer deal closed, transferring 9,226,068 shares of Samsung Bioepis to Biogen…

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Former Genentech Employees Accused of Stealing Biologic Manufacturing Process Trade Secrets

On October 25, 2018, the U.S. Attorney for the Northern District of California filed an indictment against four individuals (three of whom were former Genentech employees) alleging theft of trade secrets, computer fraud and abuse, and other crimes.  The indictment alleges that the defendants stole trade secrets related to Genentech’s products…

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Coherus Plans to Launch UDENYCA (pegfilgrastim-cbqv) in U.S. in January at 33% Discount

On November 8, 2018, on its quarterly earnings call for Q3 2018 (transcript available here), Coherus BioSciences provided updates regarding its commercial launch plans for its recently approved Udenyca™ (pegfilgrastim-cbqv) biosimilar product.  President, CEO and Chairman Denny Lefler told financial analysts on the call that Udenyca™ will be available for…

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Coherus Files Responsive Appellate Brief in Amgen v. Coherus (pegfilgrastim)

As we previously reported, Amgen is appealing the District Court’s decision to dismiss, with prejudice, Amgen’s patent infringement complaint against Coherus regarding its (recently approved) biosimilar of Neulasta® (pegfilgrastim). Amgen filed its opening brief on August 20, challenging the district court’s dismissal of the suit. On October 31, 2018, Coherus filed…

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