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  • Sam Chun Dang seeks EMA approval for its Eylea biosimilar
  • by Nho, Byung Chul | translator Kim, Jung-Ju | Mar 15, 2024 05:48am
Applies for approval of its Eylea biosimilar (SCD411) to the European Medicines Agency

Sam Chun Dang Pharm announced today that its European partner has simultaneously filed for approval of both vial and prefilled syringe formulations of its Eylea biosimilar (SCD411) in Europe. The application is notable as it is the first application filed in Europe following Korea for the prefilled syringe formulation.

The application will undergo the EMA¡¯s Centralised Procedure (CP). If the European Medicines Agency (EMA) reviews and approves the application, the drug will be approved simultaneously in more than 30 European countries.

An official from Sam Chun Dang Pharm said, ¡®The pre-filled syringe formulation is more difficult to develop than vials due to difficulty in developing the manufacturing proce
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