Sam Chun Dang Pharm: "FDA Pre-ANDA Meeting Approved, Confirming Generic Development Path"

[Financial News] Sam Chun Dang Pharm announced on the 7th that its Pre-ANDA meeting with the U.S. Food and Drug Administration (FDA) has been officially approved.
The company explained, "Under FDA regulations, the Pre-ANDA program is only available for products that are eligible for an Abbreviated New Drug Application (ANDA). Therefore, the very fact that the meeting was granted means that the generic development pathway for oral semaglutide has been officially recognized."
In practice, the FDA accepts Pre-ANDA meetings only when generic drug development is assumed, and applications are rejected at the submission stage if the development strategy does not align with the ANDA pathway. Accordingly, this meeting approval indicates that Sam Chun Dang Pharm’s product has met the generic requirements and has moved on to the next stage.
According to the company, discussions with the FDA are not based on a mere development plan, but are proceeding on the basis of bioequivalence (BE) study data that have already been secured. Sam Chun Dang Pharm said it has submitted these data to the FDA, and that the agency is currently reviewing whether the study results and protocol satisfy the approval requirements.
In particular, Sam Chun Dang Pharm has adopted an SNAC-free bioequivalence strategy in line with the FDA’s guideline for oral semaglutide. On this basis, the company maintains that it can move forward via the ANDA route without conducting separate clinical trials. The company noted, "Since we have secured a study design and data that meet the FDA’s requirements, we have entered the substantive phase of the generic approval process."
However, the company added, "Specific details on the outcome of the Pre-ANDA meeting will be provided separately at a later date."
A Sam Chun Dang Pharm representative stressed, "This Pre-ANDA meeting approval is an important milestone that removes regulatory uncertainty over the development pathway," and added, "We plan to proceed with the subsequent approval procedures without delay."


kakim@fnnews.com Kim Kyung-a Reporter