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Momenta Becomes the Latest to Settle With AbbVie Over Humira
Momenta Pharmaceuticals announced yesterday that it has reached a settlement with Humira-maker AbbVie over a proposed biosimilar adalimumab, M923.
Momenta Pharmaceuticals announced yesterday that it has reached a settlement with Humira-maker AbbVie over a proposed biosimilar adalimumab, M923.
Under the terms of the deal, Momenta will be free to launch its biosimilar in the European Union upon approval of the drug by the European Medicines Agency (EMA), and in the United States on November 20, 2023.
Momenta says that it plans to submit its Biologics License Application for M923 to the FDA before the end of the year, and its marketing authorization application to the EMA in the first half of 2019.
Momenta did not specify whether the settlement includes the payment of royalties to AbbVie, though several other recent adalimumab settlements—such as one struck last month between AbbVie and Sandoz—have done so.
"We are pleased to have been able to work with AbbVie on these agreements as they provide clarity as to when we will have the opportunity to expand treatment access and provide an additional high-quality option for patients who suffer from chronic inflammatory diseases," said Craig Wheeler, president and CEO of Momenta, in a statement announcing the deal.
News of the deal comes on the heels of an announcement that Momenta has scaled back its biosimilar ambitions. Last month, the drug maker revealed that, after a review of its operations, the company determined that it will focus novel therapeutics in the years ahead, and will only proceed with 2 late-stage biosimilars, M923 and M710 (aflibercept).
The aflibercept candidate, referencing Eylea, is being developed in conjunction with Mylan, and the partnership had announced in January 2018 that it would enter a pivotal clinical trial of the drug in patients with diabetic macular edema.
Among the biosimilar candidates abandoned in Momenta’s restructuring are M834—a proposed abatacept biosimilar referencing Orencia that, in 2017, failed to meet its phase pharmacokinetic endpoints in a phase 1 study—and 4 undisclosed molecules in the preclinical development stage.
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