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.
Overcoming Challenges to Improve Access and Reduce Costs
November 12th 2024Biosimilars hold the potential to dramatically lower health care costs and improve access to life-changing treatments, but realizing this potential will require urgent policy reforms, market competition, and better education for both providers and patients.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Challenges, Obstacles, and Future Directions for Anti-TNF Biosimilars in IBD
November 9th 2024A review article on tumor necrosis factor (TNF)-α inhibitors in inflammatory bowel disease (IBD) outlined current use of anti-TNF originators and biosimilars, their efficacy and safety, the benefits and challenges of biosimilars, and the future of biosimilars in IBD.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Eye on Pharma: Henlius, Organon Updates; Meitheal Portfolio Expansion; Celltrion Zymfentra Data
November 5th 2024Henlius and Organon’s pertuzumab biosimilar met phase 3 goals; Meitheal expanded its US biosimilars; Celltrion’s subcutaneous infliximab (Zymfentra) showed monotherapy could be as effective as combination therapy for inflammatory bowel disease.