Today, AbbVie and Momenta announced that they have entered into an agreement under which AbbVie has granted Momenta a global, royalty-bearing non-exclusive license to AbbVie’s intellectual property relating to Humira® (adalimumab). According to the press releases, the deal authorizes Momenta to launch its adalimumab biosimilar, M923, in the United States on November 20, 2023, and in Europe upon approval by the European Medicines Agency. Momenta states that it plans to submit an aBLA for M923 to the U.S. FDA within a couple months, during Q4 2018, and a marketing authorization application in the European Union in the first half of 2019. As we have reported, Momenta said several months ago that it was prepared to submit an aBLA for M923, but was holding off pending the results of a strategic review. Momenta reported last month that it completed its review and plans to identify a commercial partner for further development of this product.
This is the sixth patent license agreement into which AbbVie has entered to authorize a biosimilar of Humira®, though Momenta’s U.S. license date of November 20, 2018 is the latest of the previously announced U.S. license dates. As we reported, AbbVie previously authorized the following U.S. license dates:
- Amgen: January 31, 2023
- Samsung Bioepis: June 30, 2023
- Mylan: July 31, 2023
- Fresenius Kabi: September 30, 2023
- Sandoz: September 30, 2023
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