Biocon Biologics, a subsidiary of Biocon, announced on Saturday that it has received approval from the U.S. Food and Drug Administration (USFDA) for its biosimilar version of Janssen’s blockbuster drug Stelara (Ustekinumab). The biosimilar, branded as Yesintek, is indicated for autoimmune disorders such as Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
As per a settlement and licensing agreement with Janssen, Biocon Biologics will launch Yesintek in the U.S. no later than February 22, 2025. Stelara, Janssen’s top-selling drug, generated $7 billion in U.S. sales in 2023.
The USFDA has accepted Biocon Biologics’ Biologics License Application (BLA) for bUstekinumab (Bmab 1200) under the 351(k) regulatory pathway. The approval positions Biocon Biologics to compete in a highly lucrative but competitive market, with five other biosimilars already approved by the USFDA and set to launch in the fourth quarter of FY25. Notably, Amgen’s Stelara biosimilar will debut first, with a market entry scheduled no later than January 1, 2025.
As reported by economictimes, Biocon Biologics has also secured regulatory clearance for its Ustekinumab biosimilar in Europe, the United Kingdom, Canada, and Japan, further expanding its global footprint.
Ustekinumab is a human monoclonal antibody that targets and inhibits interleukins IL-12 and IL-23, key drivers in immune-related diseases. The launch of Yesintek is expected to bolster Biocon Biologics’ revenue and profitability, contributing to its growth despite stiff market competition.