Coherus Settles with AbbVie, and Sues Amgen, Over Adalimumab Biosimilars (Updated)

Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’ proposed adalimumab biosimilar.  According to the press release, the “global settlements resolve all pending disputes between the parties related to Coherus’ adalimumab biosimilar,” with Coherus’s U.S. license set to commence on December 15, 2023, the latest such U.S. license date announced so far.  The press release further indicates that Coherus anticipates filing an aBLA with the FDA in late 2019, and expects to launch the biosimilar, if approved, in late 2023, with its “own sales force and deliver significant top-line growth thereafter.”  Coherus also reports that it “continues to evaluate options and potential strategies for ex-U.S. commercialization of CHS-1420.”

This is the eighth patent license agreement into which AbbVie has entered to authorize a biosimilar of Humira® in the United States.  Based on prior public disclosures, AbbVie has now granted U.S. license dates for adalimumab biosimilars as follows:

  1. Amgen: January 31, 2023
  2. Samsung Bioepis: June 30, 2023
  3. Mylan: July 31, 2023
  4. Fresenius Kabi: September 30, 2023
  5. Sandoz: September 30, 2023
  6. Momenta: November 20, 2023
  7. Pfizer: November 20, 2023
  8. Coherus: December 15, 2023

In another new wrinkle in the adalimumab biosimilar arena, on January 24, 2019, Coherus filed a complaint against Amgen in the District of Delaware alleging infringement of U.S. Patent Nos. 10,155,039, 10,159,732, and 10,159,733, three related patents that issued in December 2018.  The patents claim “stable aqueous pharmaceutical compositions” comprising adalimumab and other components.  Coherus alleges that “Amgen is actively offering for sale and selling Amgevita™ [Amgen’s tradename for its adalimumab biosimilar in Europe] throughout Europe” and actively manufacturing Amgevita™ in the United States for sale in Europe.”  Amgen launched Amgevita™ in markets across Europe last year, on October 16, 2018.  According to Coherus, the commercial manufacture of Amgevita™ in the United States constitutes an act of infringement of the three asserted patents, that warrants an award of “damages adequate to compensate for past, present, and future infringement” and the grant of an injunction that permanently enjoins Amgen from engaging in further alleged infringement.  The case has been docketed as Civil Action No. 19-cv-00139.

This new case appears to be the first “biosimilar versus biosimilar” patent litigation in the United States.  Stay tuned to Big Molecule Watch for further developments.

UPDATE (March 18, 2019):  On March 5, 2019, Coherus filed a first amended complaint, adding allegations of infringement of U.S. Patent No. 10,207,000. Like the other asserted patents, the ‘000 patent claims a “stable aqueous pharmaceutical composition” comprising adalimumab and other components. Amgen’s answer to the first amended complaint is due on April 18th.

 

 

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