Biocon Gets U.S. FDA Approval For Yesintek; Shares Rise 0.79%

Mumbai, August 18: Biocon Limited said its U.S. subsidiary has received supplemental approval from the U.S. Food and Drug Administration for single-dose prefilled autoinjectors of Yesintek, a ustekinumab product used in the treatment of several inflammatory conditions.

The approval covers Yesintek 45 mg/0.5 ml and Yesintek 90 mg/ml single-dose prefilled autoinjectors. The company said Yesintek had originally received U.S. FDA approval on November 29, 2024.

The new presentation gives patients another way to receive the medicine and is intended to support more tailored treatment across different healthcare settings, according to Biocon’s company statement.

Yesintek is indicated for moderate to severe plaque psoriasis and active psoriatic arthritis in adults and paediatric patients aged six years and older. It is also indicated for moderately to severely active Crohn’s disease and ulcerative colitis in adults.

Stock Market Snapshot

Biocon shares moved higher in early trading following the regulatory announcement.

As of 9:43 AM IST on August 18, 2026, the Biocon share price stood at ₹415.25, up ₹3.25, or 0.79%, according to the market data provided.

The stock opened around ₹414.75 and moved up to ₹415 during the early session before briefly slipping below ₹413. It later recovered and was trading near the day’s high at the latest available timestamp.

The FDA approval adds another delivery format to Biocon’s U.S. immunology portfolio, with the company highlighting the broader availability of treatment options for patients.

Yesintek Expands Biocon’s U.S. Immunology Portfolio

Biocon said the supplemental approval strengthens its portfolio of immunology products in the United States.

The company is positioning the prefilled autoinjector as an additional treatment option rather than a new indication for Yesintek. The approval therefore expands how the existing medicine can be delivered to eligible patients.

The statement also said the development supports Biocon’s focus on improving access to medicines in the U.S. and other markets.

Conclusion

The U.S. FDA’s supplemental approval gives Biocon’s Yesintek portfolio two single-dose prefilled autoinjector presentations, covering 45 mg/0.5 ml and 90 mg/ml strengths.

Biocon shares were up 0.79% at ₹415.25 as of 9:43 AM IST on August 18, 2026, after the company disclosed the regulatory approval.

Source:

• https://www.nseindia.com/get-quote/equity/BIOCON/Biocon-Limited
• https://nsearchives.nseindia.com/corporate/BIOCON_18082026083950_CoStatement18062026.pdf