Momenta Pharmaceuticals Provides Update on US Regulatory Strategy for M923, Proposed Biosimilar to HUMIRA

Momenta Pharmaceuticals, a biotechnology company with a validated scientific platform focused on discovering and developing novel therapeutics to treat rare, immune-mediated diseases, 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 (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.

“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,” said Craig Wheeler, President and Chief Executive Officer of Momenta.