Momenta Pharmaceuticals announced that after a strategic review of its operations, the company will refocus on novel therapeutics rather than on biosimilars.
Yesterday, Momenta Pharmaceuticals announced that after a strategic review of its operations, the company will refocus on novel therapeutics rather than on biosimilars.
Momenta says that its 5-year restructuring plan, which involves layoffs of 50% of its staff—or 110 workers—will produce approximately $250 million in savings, but it adds that it will need to conduct additional fundraising activities in the coming years.
Read more about Momenta and its biosimilars.
Momenta noted that it will continue to develop 2 of its late-stage biosimilars: M923, Momenta’s wholly owned proposed adalimumab biosimilar referencing Humira, and M710, a proposed aflibercept biosimilar referencing Eylea.
The aflibercept candidate 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.
Mylan also partnered with Momenta on 5 additional biosimilar products, including an abatacept (Orencia) candidate for which the companies have completed a phase 1 study that failed to meet its primary pharmacokinetic end points, and 4 undisclosed biosimilar candidates in preclinical development. Momenta indicated that it is discussing the future of these products with Mylan.
When Mylan and Momenta first announced their partnership in early 2017, the deal was expected to generate up to $245 million for Momenta, based on milestone payments tied to achievements. At the time, the companies expected to submit the adalimumab product for regulatory approval in 2017, with a commercial launch planned for 2018.
Momenta’s unreached biosimilar goals and its subsequent change of course raise questions about the sustainability of biosimilar development for smaller companies. With high development costs, an uncertain patent landscape, and sluggish biosimilar uptake in the United States, it remains to be seen whether smaller ventures, even in partnership with more established companies, will be able to make their biosimilar efforts financially feasible.
From Amjevita to Zarxio: A Decade of US Biosimilar Approvals
March 6th 2025Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.
How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment
March 9th 2025Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
The Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.