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.

Motion to Dismiss Denied in Remicade Antitrust Suit

The District Court for the Eastern District of Pennsylvania has denied Johnson & Johnson and Janssen’s (“J&J”) motion to dismiss antitrust claims filed by Walgreens and Kroger concerning sales of J&J’s Remicade.  In the case, the retailers allege antitrust injury based on higher prices paid to distributors Amerisource Bergen and Cardinal…

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PTAB Issues Final Written Decisions Finding Two Of Sanofi’s Lantus Patents Invalid

Yesterday, December 12, 2018, the Board issued Final Written Decisions finding Claims 1-25 of U.S. Patent No. 7,476,652 (IPR2017-01526) and Claims 1-20 of U.S. Patent No. 7,713,930 (IPR2017-01528) unpatentable as obvious over the prior art.  IPR2017-01526 and IPR2017-01528 were two of a number of IPR petitions filed by Mylan against…

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Biosimilars Council: Express Scripts’s National Preferred Flex Formulary is an Opportunity for Biosimilars

Express Scripts has announced “a new drug reimbursement list with lower U.S. prices for brand-name medications, as a way to encourage drugmakers to move away from paying rebates after a prescription is filled.”  You can read Express Scripts’s press release here.  According to the Biosimilars Council, this could provide a particular opportunity…

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Coherus Enters into Prime Vendor Agreement with Apexus that Includes Udenyca™

Last week, Coherus BioSciences, Inc. announced that it had entered into a 340B prime vendor program contract agreement with Apexus, LLC.  This agreement includes Udenyca™, which, as we reported last month, is the second biosimilar of Neulasta® (pegfilgrastim) to have received FDA approval.  According to the press release, Apexus’s president, Chris Hatwig, stated…

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Global Biosimilar Development Updates

Over the past month, several drug developers announced updates regarding their biosimilar programs. Below are some highlights, in addition to the many biosimilar developments on which we have already reported: Today, December 3, 2018, Celltrion announced that the European Medicines Agency (EMA) has accepted Celltrion’s Extension Marketing Authorisation Application for…

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AbbVie and Pfizer Settle Adalimumab Biosimilar Patent Disputes

Today, AbbVie and Pfizer announced that they reached a global resolution of all intellectual property-related litigation concerning Pfizer’s proposed biosimilar adalimumab.  According to the press releases, AbbVie has granted Pfizer a non-exclusive license to AbbVie’s intellectual property relating to adalimumab in the United States and other countries.  All litigation pending between the parties…

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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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