Research & Development
Momenta Pharmaceuticals revises US M923 regulatory strategy
5 December 2018 -

US-based Momenta Pharmaceuticals has revised its regulatory strategy in the US for its anti-FcRn antibody M923, which the company has proposed as a biosimilar to Humira, it was reported on Tuesday.

The company had indicated earlier that it planned to file a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) in the fourth quarter of 2018.

With the recent Abbvie agreement, Momenta will be able to commercialise M923 in the United States, pending regulatory approval, as early as November 20, 2023. The company has decided to delay the filing of the BLA, which is likely to reduce programme costs in 2019 without delaying M923's potential US market entry.



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