Biocon Biologics Enters the $10.4 Billion Stelara Market with EU Approval for Yesintek
Securing Commercialization Rights with European Approval
Biocon Biologics, a subsidiary of Biocon Limited (NSE: BIOCON, BSE: 532523), has received marketing authorization from the European Commission for Yesintek (ustekinumab) on February 14, 2025. This follows the positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) on December 14, 2024, marking the final regulatory milestone, with the product now in the approval phase. Yesintek is a biosimilar to Johnson & Johnson's (JNJ) Stelara (ustekinumab), targeting the p40 subunit shared by interleukin-12 and interleukin-23. While the approval applies to all EU member states, actual sales will depend on pricing and reimbursement listings in each country, as well as the completion of hospital tenders.
Multiple Autoimmune Indications and Clinical Significance
The approved indications include adult plaque psoriasis and psoriatic arthritis, adult Crohn's disease and ulcerative colitis, and pediatric plaque psoriasis (6 years and older). Securing the same indications as Stelara signifies that the product has demonstrated high similarity in terms of quality, efficacy, and safety through analytical, non-clinical, and clinical comparative data. This approach leverages biosimilar extrapolation, reducing development costs and time, rather than requiring a separate Phase 3 clinical trial for each indication. For patients, this expands access to a proven IL-12/23 inhibition mechanism while providing healthcare institutions and payers with more options for selecting cost-effective treatments.
The $10.4 Billion Blockbuster Faces Patent Expiry
The original Stelara generated global sales of $10.86 billion in 2023 and $10.36 billion in 2024. The decline in sales reflects the impact of biosimilar launches in Europe and the weakening of its market exclusivity. The economic opportunity for Yesintek is clear, based on this established annual revenue, which exceeds separate market research estimates. However, as more biosimilars enter the market, both price discounts and bidding competition will intensify. For Biocon Biologics, adding an immunology product to its existing insulin and monoclonal antibody biosimilar business enhances the utilization of its European commercial infrastructure.
Limited Upside Potential Due to Intense Competition
In Europe, Yesintek will compete with Pyzchiva (Samsung Bioepis), Steqeyma (Celltrion (KRX: 068270)), Wezenla (Amgen (AMGN)), Uzpruvo (Alvotech (ALVO) and STADA), and Otulfi (Fresenius Kabi). In addition to the existing standard of care, Stelara, TNF inhibitors, and IL-23 selective inhibitors are also included in the competitive landscape, narrowing the scope for differentiation beyond price. The success of subsequent products will depend on factors such as supply stability, pre-filled syringe formulations, country-specific tender discounts, and hospital conversion agreements, rather than clinical data. This approval secures essential market access, but market share and profitability will be determined by the number of countries launched, the speed of reimbursement listings, and production costs.
With Stelara recording $10.36 billion in sales in 2024, the approval of Yesintek allows Biocon Limited (BIOCON) to expand its European immunology portfolio and enhance the utilization of its commercial infrastructure. From a research perspective, this case demonstrates the successful comparative validation of an IL-12/23 p40 targeting antibody and the application of indication extrapolation from plaque psoriasis to inflammatory bowel disease. Short-term sales will be linked to country-specific reimbursement listings and hospital tender schedules, with Pyzchiva, Steqeyma, Wezenla, Uzpruvo, and Otulfi already establishing price competition. In the industry, the entry of multiple biosimilars increases treatment access while simultaneously putting downward pressure on the prices of both originator and follow-on products. In the medium to long term, corporate value will be determined by launch scope, supply reliability, tender market share, and gross profit margin, rather than the approval itself.
Source: EMA (ema)