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  • Eylea biosimilar by SCD applies for Phase 3 global IND
  • by Lee, Seok-Jun | translator Byun Kyung A | Jan 29, 2020 06:25am
Planning to apply for IND in the U.S. Q1, result would be out within 90 days
Global trial in each region including the U.S. would start from Q2 at earliest
To receive USD 3 million as milestone payment from Japan
Samchundang Pharm (SCD) plans to have Phase 3 global clinical trial protocol approved for Eylea¡¯s biosimilar ¡®SCD411¡¯ within the first quarter of the year. The protocol approval would be reviewed for 90 days at longest, and green light the company to start the Phase 3 trial by the coming second quarter.

The multiregional study is planned to be conducted in the U.S., Europe and Japan with a set number of participants. When the trial in Japan starts, SCD would receive USD 3 million (about 3.4 billion won) as a milestone payment stated on the substance license-out deal.

According to pharmaceutical industry on Jan. 23, SCD is submitting an Investigational New Drug (IND) application to the U.S. Food and Drug Ad
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