Samchundang Pharmaceutical announced on the 5th that, following the receipt of the contract payment in December last year, it has received an additional milestone payment from its European partner for the submission of the European Medicines Agency (EMA) approval application for the Aflibercept biosimilar 'SCD411'.
The milestone was received after the submission of the approval applications for the SCD411 prefilled syringe (PFS) and vial, and after receiving the 'Acceptance Letter' from the EMA confirming that all approval documents were complete and without issues.
A company representative explained, "As planned, we received the Acceptance Letter after the approval application, and our partner is positively evaluating the situation with expectations that the final approval may come sooner than anticipated, as well as the fact that it does not infringe on the original company's patent." They added, "This situation is an important factor that increases the likelihood of SCD411 being launched as the first biosimilar."
They continued, "We will diligently prepare for the remaining approval review process to complete it without issues and obtain the approval."
Samchundang Pharmaceutical received the final clinical report for SCD411 in March last year and is currently proceeding with the process to obtain approval.
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