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FDA Approves IMULDOSA

Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug Administration (FDA) has approved IMULDOSA (ustekinumab-srlf), a biosimilar to STELARA® (ustekinumab), for the treatment of chronic inflammatory conditions, including psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

The FDA approved IMULDOSA for all indications of its reference medicine, STELARA. Accord anticipates a commercial launch of IMULDOSA in the first half of 2025.

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