Momenta Pharmaceuticals, Inc. (MNTA)

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Momenta provides update on U.S. regulatory strategy for Humira biosimilar


Momenta Pharmaceuticals (MNTA) announced a revised regulatory strategy in the United States for M923, Momenta's proposed biosimilar to Humira.

Momenta had previously guided that it planned to file a Biologics License Application, or BLA, to the FDA in Q4 of this year. With the recent Abbvie (ABBV) 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.

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