Global Biosimilar Market Update: Secukinumab Biosimilar Approval in China and Expanded Ustekinumab Licensing Rights

On October 26, 2026, Bio-Thera Solutions announced that China’s National Medical Products Administration (“NMPA”) approved BAT2306, its biosimilar to COSENTYX® (secukinumab). BAT2306 will be marketed as YOUZHUOMEI® and is approved for psoriasis, ankylosing spondylitis, and psoriatic arthritis. According to Bio-Thera, BAT2306 is the first secukinumab biosimilar approved in China.

Bio-Thera also reported that it has entered into commercialization agreements for BAT2306 covering markets in the Middle East and North Africa, Latin America, and Southeast Asia.

Also on October 26, 2026, Biocon Limited announced a license agreement with Janssen Sciences Ireland providing commercialization rights for YESINTEK®, its proposed biosimilar to STELARA® (ustekinumab), in nine additional markets: Australia, Brazil, China, Hong Kong, Israel, Mexico, New Zealand, South Korea, and Kazakhstan. Biocon stated that the agreement builds on its previously announced agreements with Janssen establishing market entry dates for YESINTEK® in the United States, Europe, the United Kingdom, Canada, and Japan.

YESINTEK® has been approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. According to Biocon, the additional market entry rights take immediate effect, although product launches in all covered countries and regions remain subject to regulatory approval. The reference product, STELARA®, had worldwide sales of $6.08 billion in 2025.

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