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  • Sam Chun Dang Pharm¡¯s biosimilar equivalent to Eylea
  • by Nho, Byung Chul | translator Kim, Jung-Ju | Mar 28, 2023 05:56am
demonstrates equivalence in global Phase III trial

On the 27th, Sam Chun Dang Pharm announced that it had received the final result report for its Phase III trial for SCD411 (Eylea biosimilar). The results are from a global phase III clinical trial that had been conducted on 576 patients at 132 hospitals in 14 countries from September 2020 to September 2022.

Through the global Phase III trial, the company demonstrated the equivalence of SCD411 to the original Eylea in terms of efficacy (primary endpoint & secondary endpoint), safety, tolerance, effectiveness, and immunogenicity.

The primary outcome measure, change from baseline in BCVA (best corrected visual acuity) measured from baseline to Week 8, fell within the equivalence limit interval set by the US FD
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