Biocon Biologics Ltd.,the subsidiary of Biocon Ltd., is now a forerunner in achieving an important milestone; the Pharmaceuticals and Medical Devices Agency, Japan, has granted regulatory approval for its biosimilar version of Ustekinumab. Known as Ustekinumab BS, this is a subcutaneous injection intended to be a biosimilar to Stelara, the monoclonal antibody used so widely to treat autoimmune diseases developed by Johnson & Johnson.

With this approval from PMDA, Biocon Biologics is now authorized to market Ustekinumab BS in Japan, focusing on conditions such as Psoriasis Vulgaris and Psoriatic Arthritis. Both of these chronic immune-related diseases typically require long-term management, with Stelara being a key treatment option in this therapeutic area.

The biosimilar will be commercialized in Japan by Yoshindo Inc., Biocon Biologics’ exclusive partner in the region. This collaboration is expected to strengthen Biocon Biologics’ foothold in the Japanese market, which is one of the largest pharmaceutical markets globally.

The approval follows Biocon Biologics’ settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson, announced in August 2024. This agreement resolved intellectual property disputes and paved the way for the global commercialization of Ustekinumab biosimilars.

Ustekinumab is a monoclonal antibody targeting interleukin-12 (IL-12) and interleukin-23 (IL-23), which are critical drivers of inflammation in autoimmune diseases. It has been a cornerstone therapy for Psoriasis Vulgaris and Psoriatic Arthritis, offering significant relief from symptoms and improving patients’ quality of life.