Imuldosa® Gains CHMP Approval as Biosimilar to Stelara® in Europe

Imuldosa®, a biosimilar to Stelara®, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), paving the way for its authorization in Europe. Developed by Accord Healthcare and Intas Pharmaceuticals, Imuldosa® intends to expand access to high-quality biologic therapies for immunology conditions.

Accord Healthcare has announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Imuldosa®, a biosimilar to Stelara®, setting the stage for its approval in the European market.

The decision follows rigorous trials, highlighting Imuldosa's therapeutic equivalence to Stelara® and reinforcing its safety profile. The European ustekinumab market, valued at approximately €2.9 billion, stands to benefit from the introduction of this new treatment option.

Intas Pharmaceuticals, through its global subsidiaries, plans to commercialize Imuldosa® worldwide, excluding Japan, Korea, and select Asian countries, enhancing its already robust biosimilar pipeline.

(With inputs from agencies.)