SINGAPORE, Oct 14 (Bernama-BUSINESS WIRE) — Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, has submitted a request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting to discuss the company’s planned Biologics License Application (BLA) for its Herceptin Biosimilar, HD201(Tuznue®).
The Biosimilar Biological Product Development (BPD) Type 4 Meeting is to discuss the format and content of a BLA in advance of the final submission. The company will discuss the overall development program of HD201 with the FDA to identify potential filing and review issues. The meeting is expected to take place around November, and the BLA submission by the end of the year.