Momenta Pharmaceuticals has revised its regulatory strategy in the US for its anti-FcRn antibody M923, which is being proposed by the company as a biosimilar to Humira.
Momenta had previously guided that it planned to file a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of this year.
With the recent Abbvie agreement, Momenta will be able to commercialize M923 in the United States, pending regulatory approval, as early as November 20, 2023. Momenta has decided to delay the filing of the BLA, which may reduce program costs in 2019 without delaying potential US market entry for M923.
Momenta president and CEO Craig Wheeler said: “The clarity on the US entry date provided by our settlement with Abbvie allows us to better align our regulatory and manufacturing strategies and enables us to defer expenses without impact to our launch timing.”
Momenta is a biotechnology company with a validated innovative scientific platform focused on discovering and developing novel therapeutics to treat rare, immune-mediated diseases. Momenta’s lead product candidate, M281, is a potentially best-in-class anti-FcRn antibody; M254, is a hyper-sialylated human immunoglobulin (hsIgG) designed as a high potency alternative to intravenous immunoglobulin (IVIg); and M230 (CSL730), is a potential first-in-class novel recombinant Fc multimer being developed in collaboration with CSL.
Momenta also has a focused pipeline of two biosimilar candidates: M923, Momenta’s wholly-owned proposed biosimilar to Humira , and M710, a proposed biosimilar to Eylea being developed in collaboration with Mylan.
Momenta’s two FDA-approved complex generic products, enoxaparin sodium injection and Glatopa (glatiramer acetate injection), are marketed by its collaboration partner, Sandoz.
Source: Company Press Release