Prime Highlights :
- Biocon launched Yesafili in the US after receiving FDA approval and interchangeable designation for pharmacy-level substitution.
- The company also expanded its global biosimilar business with approvals for Yesintek in Canada and a new Semglee production line in Malaysia.
Key Facts :
- Biocon Ltd. is an Indian biopharmaceutical company focused on biosimilars, generic formulations and research-driven healthcare products.
- Yesafili is a biosimilar of EYLEA 2 mg and is used to treat several ophthalmology conditions, including age-related macular degeneration.
Background :
Biocon Ltd. has commercially launched Yesafili (aflibercept) in the United States, strengthening its biosimilars portfolio in one of its key global markets. The medicine is used to treat several eye diseases and is a biosimilar version of EYLEA 2 mg. The product received approval and an interchangeable designation from the US Food and Drug Administration earlier, allowing pharmacists to substitute it for the reference medicine under applicable state laws.
The company said the launch is expected to improve access to treatment for patients with eye disorders. Age-related macular degeneration (AMD), one of the major conditions treated with aflibercept, remains a leading cause of permanent vision loss among older adults. Around 19.8 million Americans are living with AMD, while US sales of aflibercept reached nearly $5.89 billion in 2023.
Biocon’s management said the commercial launch marks an important step in expanding the global availability of biosimilar aflibercept for patients requiring eye care treatment.
The company also reported progress in other international markets. Its Canadian subsidiary recently received Health Canada approval for the Yesintek (ustekinumab) Autoinjector. The approval follows earlier clearance for prefilled syringe, vial and intravenous infusion formats. Biocon said the autoinjector offers patients an additional treatment option that is not available with the originator product.
In another development, Biocon’s Malaysia unit received European Medicines Agency approval for a new fill-finish production line for Semglee (insulin glargine). The company expects supplies to Europe from the new facility to begin in the second quarter of the current financial year.
Biocon shares traded nearly unchanged after recovering from early losses.
