Samchundang Pharmaceutical Applies for European Approval of Ailia Biosimilar

Samchundang Pharmaceutical announced on the 14th that its European partner has simultaneously submitted marketing authorization applications for two products of the Ailia biosimilar (SCD411): vials and prefilled syringes. This authorization application is drawing attention as it is the first prefilled syringe product to be submitted in Europe following its domestic release.

The current authorization application is being processed through the Centralized Procedure (CP). Once approved by the EMA (European Medicines Agency), marketing authorizations will be granted simultaneously in over 30 European countries.

A company representative stated, “Our partner has confirmed that this is the first prefilled syringe product authorization application in Europe following its domestic submission. The prefilled syringe is an essential element for macular degeneration treatments. Although developing prefilled syringes is much more challenging than vials due to patent circumvention and complex production processes such as sterilization, Samchundang Pharmaceutical focused all its capabilities on developing the prefilled syringe product, completing development ahead of competitors and enabling the authorization application.”

They continued, “Additionally, to shorten the review period and achieve rapid market entry through simultaneous approval, we proceeded with the Centralized Procedure (CP). The application was actually submitted some time ago, but disclosure was delayed due to the process of agreeing with our partner on the timing of public announcement, which is why it is only now being disclosed.”

Samchundang Pharmaceutical submitted marketing authorization applications domestically and in Europe last March based on the final report of the Phase 3 clinical trial of the Ailia biosimilar, and is currently negotiating supply contracts with partners in the United States, Russia, and the Middle East.

A company representative added, “Finally, negotiations for contracts in the rest of Europe beyond the five countries signed last November are nearing completion, and we are doing our best to share good news soon. We ask for your understanding that we cannot disclose the progress of authorization processes in regions outside Europe at the request of our partners.”

This content was produced with the assistance of AI translation services.