Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has achieved a significant milestone with the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan granting regulatory approval for its Ustekinumab biosimilar. The biosimilar, Ustekinumab BS, is a subcutaneous injection designed to replicate Johnson & Johnson’s Stelara®, a widely used monoclonal antibody for autoimmune conditions.
The PMDA’s approval allows Biocon Biologics to market Ustekinumab BS in Japan, targeting conditions such as Psoriasis Vulgaris and Psoriatic Arthritis. These chronic immune-mediated conditions often require long-term management, and Stelara® has been a pivotal treatment option in this space.
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.
