Biocon Gets US FDA Supplemental Approval for Yesintek Prefilled Autoinjectors
Biocon’s US unit received FDA supplemental approval for two new single-dose prefilled autoinjector presentations of Yesintek, expanding treatment delivery options for chronic autoimmune diseases. The FDA cleared Yesintek 45 mg/0.5 ml and 90 mg/ml autoinjectors after its initial Nov 2024 approval, broadening Biocon’s immunology portfolio and aiming to improve patient access across care settings.