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Biocon Biologics Launches YESINTEK Biosimilar in US for Autoimmune Diseases

Synopsis:

Biocon Biologics has launched YESINTEK, a biosimilar to Stelara, in the US for treating autoimmune diseases. Approved by the FDA in December 2024, YESINTEK will be available in multiple formulations. Biocon share price ended at ₹321.30, down 0.23% on the BSE.


Biocon Biologics, a subsidiary of Biocon Ltd, has officially launched YESINTEK (ustekinumab-kfce) in the US market, making it one of the first biosimilars to Stelara. The biosimilar is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, offering a more affordable treatment option for patients with chronic autoimmune conditions. The approval from the US Food and Drug Administration (FDA) was granted in December 2024.

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BIOCON LIMITED.

Trade

325.1-3.79 (-1.15 %)

Updated - 12 March 2025
330.90day high
DAY HIGH
323.40day low
DAY LOW
1536760
VOLUME (BSE)

Key Takeaways

  • Biocon Biologics introduces YESINTEK in the US, a biosimilar alternative to Stelara.

  • It is approved for Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

  • Available in multiple formulations, including 45 mg/0.5 mL PFS and 130 mg/26 mL vial.

  • FDA approved YESINTEK in December 2024, confirming its similarity to Stelara.

  • Biocon share price closed at ₹321.30 on BSE, down 0.23%.

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Market Impact & Product Accessibility

YESINTEK’s launch in the US expands treatment accessibility for patients suffering from autoimmune diseases. The biosimilar, a monoclonal antibody, disrupts IL-12 and IL-23 mediated signaling, essential in immune-mediated conditions. Clinical trials demonstrated comparable efficacy, safety, and immunogenicity profiles to Stelara, supporting its FDA approval.

YESINTEK will be available in the same formulations as Stelara, ensuring seamless transition for healthcare providers and patients. Additionally, a patient assistance programme has been introduced, offering benefits verification, copay support, and financial assistance, with eligible patients paying as little as $0 under the scheme.

Available Formulations of YESINTEK

Formulation

Dosage

Pre-Filled Syringe (PFS)

45 mg/0.5 mL

Pre-Filled Syringe (PFS)

90 mg/mL

Vial

45 mg/0.5 mL

Vial

130 mg/26 mL

Biocon Share Price & Market Response

Following the announcement, Biocon share price declined slightly, closing at ₹321.30 on BSE, reflecting a 0.23% dip. Investors are closely monitoring the biosimilar’s market reception, as its successful uptake could impact Biocon’s revenue and market positioning in the biologics segment.

Biocon Biologics’ launch of YESINTEK strengthens its biosimilar portfolio and reinforces its commitment to expanding affordable treatment options in the US. As one of the first Stelara biosimilars in the market, YESINTEK could drive competition, benefiting patients and healthcare providers alike. The industry will be watching closely for market adoption trends and future biosimilar launches from Biocon.

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