Biocon Biologics Scores EC Approval for Biosimilar to Ustekinumab

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India-based Biocon Biologics, a biosimilars company and subsidiary of Biocon Ltd, has been granted marketing authorization in the European Union (EU) by the European Commission (EC) for its biosimilar ustekinumab product (brand name YESINTEK), referencing the originator biologic, Stelara (ustekinumab), by Janssen Biotech, a Johnson & Johnson company (1,2). The marketing authorization approval comes on the heels of a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which was issued on Dec. 14, 2024, Biocon stated in a Feb. 18, 2025 press release (1).

Biocon’s biosimilar ustekinumab is indicated in the EU for treating:

• moderate to severe plaque psoriasis in adults and children from six years of age whose condition has not improved with, or who cannot use, other systemic (whole-body) psoriasis treatments such as ciclosporin, methotrexate or psoralen ultraviolet A
• active psoriatic arthritis in adults, when the condition has not improved enough with other treatments such as disease-modifying anti-rheumatic drugs.
• moderately to severely active Crohn’s disease in adults whose condition has not improved enough with other Crohn’s disease treatments or who cannot receive such treatments (3).

The first approved biosimilar to Stelara in the European market was launched in July 2024 by STADA and Alvotech, whose biosimilar ustekinumab goes by the brand name Uzpruvo (4). The EC approved Uzpruvo in January 2024, making it the first ustekinumab biosimilar to be approved in Europe with equivalent efficacy, safety, pharmacokinetics, and immunogenicity to the reference biologic (5).

STADA and Alvotech’s biosimilar is offered in a pre-filled syringe that has a thinner needle than the reference biologic. Their product is also latex-free to minimize the risk of allergic reactions, according to the companies in a press release (4). The companies stated at the time that their product was developed and is manufactured and packaged wholly within Europe and has a shelf life of 36 months. The originator biologic, Stelara, was approved by the EC in January 2009, following a positive opinion issued by the CHMP in November 2008 (2).

In addition to the EC’s approval for its biosimilar ustekinumab (brand name YESINTEK) in Europe, Biocon Biologics also launched the product, known as ustekinumab-kfce (same brand name YESINTEK) in the United States on Feb. 24, 2025 (6), following approval by FDA in December 2024 (7).

“The launch of YESINTEK marks a significant step in our commitment to improving the lives of patients with inflammatory conditions and expanding access to high-quality biosimilars. It also represents our first product launch in the United States since becoming a fully integrated global biosimilars organization. We are excited to be among the first companies to introduce a high-quality, affordable biosimilar ustekinumab to this patient population,” said Shreehas Tambe, CEO and managing director, Biocon Biologics, in a company press release (6).

In the US launch, Biocon’s ustekinumab-kfce will be available in all the same formulations currently available for Stelara: 45 mg/0.5 mL prefilled syringe, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial. According to the company, the biosimilar will have commercial payor coverage at launch and will have a robust patient assistance program, including benefits verification and copay support, among other services. The company stated in its release that the copay program is competitive with the originator offering. Eligible patients who meet the program criteria may pay as little as $0 (6).

References

1. Biocon. European Commission Approves Biocon Biologics’ Ustekinumab Biosimilar. Press Release. Feb. 18, 2025.
2. EMA. Stelara. ema.europa.eu (accessed Feb. 24, 2025).
3. EMA. Yesintek. ema.europa.eu (accessed Feb. 24, 2025).
4. Alvotech. STADA and Alvotech launch Uzpruvo, the First Approved Ustekinumab Biosimilar to Stelara, Across Europe. Press Release. July 22, 2024.
5. European Commission. Union Register of Medicinal Products for Human Use. ec.europa.eu (accessed Feb. 24, 2025).
6. Biocon. Biocon Biologics Launches Yesintek (ustekinumab-kfce) Biosimilar to Stelara in the United States. Press Release. Feb. 24, 2025.
7. Biocon. US FDA Approves Biocon Biologics’ YESINTEK, Bmab 1200 Biosimilar to J&J’s Stelara (Ustekinumab). Press Release. Dec. 1, 2024.