Momenta settles with AbbVie regarding commercializing Humira biosimilar

Momenta Pharmaceuticals (MNTA) announced that it has executed agreements with AbbVie (ABBV) providing license rights for the global launch of M923, Momenta’s proposed biosimilar to Humira. Under the terms of the agreements and subject to approval by health regulatory authorities, Momenta may launch M923 in the United States on November 20, 2023 and in Europe upon approval by the European Medicines Agency. Momenta plans to submit a biologics license application for M923 to the FDA in Q4 of 2018 and a marketing authorization application in the European Union in the first half of 2019.
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