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FDA approves Accord BioPharma's IMULDOSA, a biosimilar for chronic inflammatory conditions.
The FDA has approved IMULDOSA (ustekinumab-srlf), a biosimilar to STELARA (ustekinumab), for treating chronic inflammatory conditions like psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Manufactured by Accord BioPharma, a subsidiary of Intas Pharmaceuticals, IMULDOSA is set for launch in early 2025.
This approval marks Accord's second biosimilar following HERCESSI, further expanding its presence in the U.S. market.
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La FDA aprueba la IMULDOSA de Accord BioPharma, un biosimilar para enfermedades inflamatorias crónicas.