Biocon shares rise 2% after USFDA approval for Yesintek single-dose prefilled autoinjector
Key Takeaways
- •Biocon's US subsidiary received supplemental USFDA approval for Yesintek single-dose prefilled autoinjectors in two strengths, lifting the company's shares by 2% in Indian trading reported on August 18, 2026.
- •Yesintek is Biocon's biosimilar of ustekinumab, Johnson & Johnson's Stelara, and is used to treat plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.
- •Stelara generated annual sales exceeding $10 billion before losing US market exclusivity in 2025, and Amgen, Sandoz and Teva-partnered Alvotech have also obtained USFDA approvals for ustekinumab biosimilars.
- •The supplemental approval extends an existing clearance to additional delivery presentations, with single-dose prefilled autoinjectors enabling patients to self-administer biologics for chronic autoimmune conditions rather than depend on clinic visits.
- •The United States is the world's largest pharmaceutical market and a key revenue region for Bengaluru-headquartered Biocon, whose businesses span biosimilars, generic formulations and active pharmaceutical ingredients.
Biocon Ltd shares rose 2% after the company's US subsidiary received supplemental approval from the US Food and Drug Administration (USFDA) for Yesintek single-dose prefilled autoinjectors in two strengths.
The clearance expands Biocon's immunology portfolio in the United States. Yesintek is used to treat conditions including plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. It is Biocon's biosimilar of ustekinumab, the Johnson & Johnson medicine sold as Stelara and one of the world's best-selling drugs, with annual sales that exceeded $10 billion before it lost US market exclusivity in 2025, an opening that set off a race among biosimilar makers. Amgen, Sandoz and Teva-partnered Alvotech are among the companies that have also secured USFDA approvals for ustekinumab biosimilars.
Under US regulatory practice, a supplemental approval extends an existing clearance to additional strengths, dosage forms or delivery presentations of an already-approved medicine. Single-dose prefilled autoinjectors are self-administration devices widely used for biologic medicines that treat chronic autoimmune conditions, a format that allows patients to inject themselves rather than rely on clinic visits. The commercial rollout of the newly approved presentation, and its uptake among US patients and payers, are the milestones that typically follow such a clearance.
The United States is the largest pharmaceutical market in the world, and USFDA approvals routinely move the shares of Indian drugmakers such as Biocon, for whom North America is a key revenue region.
Biocon, headquartered in Bengaluru, is one of India's leading biopharmaceutical companies, with businesses spanning biosimilars, generic formulations and active pharmaceutical ingredients. Its US subsidiary operates under the group's biologics arm, which markets the immunology portfolio that Yesintek forms part of.
The stock's advance on the approval was recorded in Indian market trading reported on August 18, 2026.
Source: Economic Times Markets