NEWS | Innovation for Life

SINGAPORE, November 02, 2022 – Prestige Biopharma Limited, a Singapore-based biopharmaceutical company, announced that the request to the U.S. Food and Drug Administration (FDA) for a pre-submission meeting for Herceptin Biosimilar, HD201(Tuznue®) has been accepted and the meeting has been scheduled for 14th of December this year.

The Biosimilar Biological Product Development (BPD) Type 4 Meeting is to discuss the format and content of a Biologics License Application (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 company has been preparing for FDA BLA for HD201 since 2019 when the company had the Biosimilar Initial Advisory Meeting with the FDA. The FDA bridging study was completed in 2020 and the study result was published in the international journal of Pharmacology Research & Perspectives in July 2021. The study showed HD201’s equivalent pharmacokinetic and safety profile to both US-Herceptin® and EU- Herceptin®.

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 Switzerland.