Prestige Biopharma Submitted Pre-BLA Type 4 Meeting Request to FDA for Herceptin Biosimilar

On October 13, 2022 Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, reported that it 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) (Press release, Prestige BioPharma, OCT 13, 2022, View Source [SID1234622004]).

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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.

Prestige Biopharma’s HD201 is a proposed biosimilar to Roche’s Herceptin (trastuzumab) to be prescribed for the treatment of human epidermal growth factor 2 (HER2) positive breast and metastatic gastric cancer. Trastuzumab targets HER2, which is overexpressed in some types of cancer cells and stimulates the growth of the cancer cells. Trastuzumab works by selectively binding to HER2, thereby stopping the growth of these cancer cells.

Currently, a New Drug Submission (NDS) for HD201 is under review by Health Canada and a Marketing Authorisation Application (MAA) by the Korea Ministry of Food and Drug Safety. In addition to filing a new MAA to the European Medicines Agency (EMA), the company also plans to apply for authorisation in other advanced biosimilars markets such as UK, Australia, and Singapore.

Lisa Park, CEO of Prestige Biopharma, commented: "This Type 4 Meeting will be the final gate of BLA submission for HD201. In addition to the Bridging Study on biosimilarity of HD201 to US-Herceptin and the Biosimilar Initial Advisory Meeting with FDA in 2019, we have been through a series of meetings with the FDA on each step of the development to prepare the launch of HD201 in US to help more patients in need. We will take this final step to thoroughly review and finalise the application for FDA’s approval."