Biocon Biologics launches Ustekinumab biosimilar drug in Japan after US, Europe

After the launch of Ustekinumab, a biosimilar of Stelara, in the United States and Europe, Biocon Biologics’ biosimilar drug has entered the Japanese market through its commercial partner, Yoshindo Inc.

The biosimilar Ustekinumab, developed and manufactured by Biocon Biologics, is being commercialised and marketed in Japan by Yoshindo. Ustekinumab, a monoclonal antibody, is approved for the treatment of psoriasis vulgaris and psoriatic arthritis (PsA).

In April 2024, Biocon Biologics entered into a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen), allowing it to commercialise Ustekinumab in Japan upon regulatory approval.

Biocon Biologics’ biosimilar Ustekinumab BS Subcutaneous Injection [YD] was approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) in December 2024. The company had already launched Ustekinumab in the United States and Europe in February 2025 to support patients in managing their chronic conditions.

Published on May 21, 2025