Biocon Biologics gets EMA Committee positive opinion for Yesafili
It is highly similar to the reference product Eylea (aflibercept).
Advertisement
Bengaluru: Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd has announced that the European Medicines Agency’s Commitee for Medicinal Products for Human Use (CHMP) has issued a positve opinion recommending approval of YESAFILI, an aflibercept biosimilar.
YESAFILI, an ophthalmology product, is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is highly similar to the reference product Eylea (aflibercept).
Data shows that YESAFILI has comparable quality, safety, and efficacy to Eylea. The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected by the end of September 2023.
Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said, “We are very pleased to receive a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for our YESAFILI biosimilar. This is further confirmation of our strong commitment to providing high-quality and affordable medicines and represents another significant milestone as we continue to expand our biosimilar offerings across the globe, building on our robust presence in oncology and diabetes. We look forward to making a meaningful difference to patients in the EU impacted by macular degeneration and diabetic retinopathy through YESAFILI.”
Aflibercept had EU brand sales of approximately $1.8B for the 12 months ending December 31, 2022, according to IQVIA.
"Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisaion has been granted by the European Commission," the company stated.
Aflibercept is a fusion protein consisting of portions of human VEGF (Vascular Endothelial Growth Factor) receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. YESAFILI is registered trademark of a BBL company.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.