Biocon Biologics Bags Global Entry for Biosimilar Ustekinumab in Key Markets

Biocon Biologics, a branch of Biocon, has gained access to the market for the biosimilar Ustekinumab in Europe, the United Kingdom (UK), Canada, and Japan. Ustekinumab is a human monoclonal antibody that inhibits the irregular regulation of interleukin IL-12 and IL-23 related immune disorders.

The company has obtained approval from the USFDA to introduce the biosimilar version of Janssen's Stelara (Ustekinumab), which is utilized in treating autoimmune conditions like Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

According to the settlement and licensing agreement with Janssen, Biocon Biologics is expected to introduce the drug in the US by February 22, 2025, at the latest. Stelara is the best-selling medication for Janssen, generating $7 billion in sales in the US for 2023. The biosimilar will be sold under the brand name Yesintek.

The U.S. FDA has approved the evaluation of the company’s Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) via the 351(k) pathway.

The authorization will clear the path for the introduction of the biosimilar, contributing to the company's revenue and profitability, even with strong competition from competing biosimilars. The USFDA has granted approval to five biosimilars of Stelara, anticipated to enter the market in the fourth quarter of FY25.

Amgen's biosimilar for Stelara is set to enter the global market, with a planned launch by January 1, 2025, at the latest.