Momenta Pharmaceuticals Provides Update on US Regulatory Strategy for M923, Proposed Biosimilar to HUMIRA®
With the recent
“The clarity on the US entry date provided by our settlement with
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
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Momenta’s logo, trademarks, and service marks are the property of
Statements in this press release regarding management's future expectations, beliefs, intentions, goals, strategies, plans or prospects, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements about the timing of regulatory filings, the development and commercialization plans, including target launch dates, program costs for, and the potential of, M923. Forward-looking statements may be identified by words such as "believe," "continue," “plan to”, "potential," "will," and other similar words or expressions, or the negative of these words or similar words or expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors, including the risk that the program costs savings will not be achieved, that the marketing approval process is expensive, time-consuming and uncertain and may prevent the Company from obtaining approvals for the commercialization of M923; and those referred to under the section "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ended
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Source: Momenta Pharmaceuticals, Inc.