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  • Samsung Bioepis¡¯s Eylea biosimilar Afilivu approved in KOR
  • by Son, Hyung-Min | translator Kim, Jung-Ju | Feb 26, 2024 05:24am
First Eylea biosimilar approved in Korea...will co-market the drug with Samil Pharm
"Will strive to address unmet medical needs in the field of ophthalmic diseases¡±
Samsung Bioepis announced on the 23rd that it has obtained domestic approval for its Eylea biosimilar ¡®Afilivu.¡¯

The approval marks the 2nd ophthalmic disease treatment Samsung Bioepis has received approval for after being granted approval for its Lucentis biosimilar Amelivu. Eylea is a macular degeneration treatment developed by the multinational pharmaceutical companies Regeneron and Bayer.

Samsung Bioepis plans to comarket both Amelivu and Afilivu with Samil Pharm. The companies released Amelivu last year and signed an agreement for Afilivu in February this year.

Samsung Bioepis conducted a Phase III clinical trial for its Eylea biosimilar in 449 patients with wet age-related macular degeneration from
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