european end-to-end CDMO company, pharma services
LinkedIn Share

Biocon’s Yesintek receives EMA and FDA approval as the next ustekinumab biosimilar

  • Yesintek, a biosimilar to ustekinumab developed by Biocon, has received approval from both the EMA and FDA, joining other ustekinumab biosimilars like Amgen’s Wezlana and Alvotech’s Selarsdi.
  • In the pivotal study in plaque psoriasis patients, Yesintek has demonstrated equivalence to Janssen’s Stelara in efficacy, safety, and pharmacokinetics, meeting stringent biosimilar standards.
  • The global ustekinumab market, valued at $9.7 billion in 2023, is expected to see intense competition as patents expire. With multiple biosimilars set to launch in 2025-26, companies like Biocon are poised to play a key role in expanding access to cost-effective treatments for autoimmune diseases.

Yesintek, a biosimilar to ustekinumab developed by an India-based biopharmaceutical company Biocon, has been officially approved by both the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA). This approval follows the arrival of other ustekinumab biosimilars into the European and U.S. markets, including Wezlana from Amgen and Selarsdi from Alvotech. The increasing availability of these alternatives is fostering a competitive market landscape, which can lead to further cost reduction and improved accessibility for patients.

Ustekinumab is a monoclonal antibody that targets interleukin-12 (IL-12) and interleukin-23 (IL-23), two cytokines that play a central role in the inflammatory processes underlying several autoimmune diseases. By inhibiting these cytokines, ustekinumab helps reduce inflammation and manage symptoms effectively.  Ustekinumab is approved for treating a range of conditions, including moderate to severe plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The reference product for ustekinumab, Janssen’s Stelara®, has been a key therapy in managing these conditions since its initial approval in 2009.

Biocon’s Yesintek has undergone rigorous tests to demonstrate equivalence in efficacy, safety, and quality to Stelara®. The pivotal clinical trial included 384 subjects with moderate-to-severe plaque psoriasis and used percent change in Psoriasis Area and Severity Index (PASI) endpoint for the primary comparison of efficacy, which is the most commonly employed tool for evaluating new treatments for this condition. Other assessments included pharmacokinetic equivalence, anti-drug antibody development and incidence of injection-site reactions.  Based on the results submitted by Biocon, both the EMA and FDA concluded that Yesintek meets the stringent standards required for biosimilars.

The global market for ustekinumab is substantial, with sales of Stelara® reaching $9.7 billion in 2023. Now, as the patents for Stelara® reach their expiry date, the market will be transformed into an arena of fight between several biosimilar companies. Biocon is the sixth ustekinumab biosimilar to receive FDA approval, but certainly not the last. Most of the approved products will be launched in 2025-26, creating an enormous competition.

Particularly in Europe and the U.S., the introduction of biosimilars like Yesintek is expected to drive significant changes. Biosimilars provide cost-effective alternatives that help alleviate the financial burden on healthcare systems while maintaining the therapeutic benefits of the originator biologic. With Yesintek now approved, Biocon continues to advance its portfolio of biosimilars, aiming to deliver high-quality, affordable biologic treatments to patients worldwide.

Prepared by:


Adam Tuszyner

Sources and further reading

  1. “FDA Approves First Medication for Obstructive Sleep Apnea” Food and Drug Administration (FDA) (December 20, 2024). Link: https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea.
  2. Malhotra, Atul, et al. “Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity.” New England Journal of Medicine (2024).
  3. Flam, Charna “Zepbound Weight Loss Medication Approved by FDA to Treat Sleep Apnea” People.com (December 25, 2024). Link: https://people.com/zepbound-treat-sleep-apnea-approved-fda-8766411.
  4. Park, Alice “The First Sleep Apnea Drug Is Here.” Time (December 20, 2024). Link: https://time.com/7203597/zepbound-sleep-apnea-fda/.
Share LinkedIn