PRESTIGE BIOPHARMA SUBMITS PRE-BLA TYPE 4 MEETING REQUEST TO FDA

KUALA LUMPUR, Oct 14 (Bernama) -- 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, according to a statement.

The company will discuss the overall development programme 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.

“This Type 4 Meeting will be the final gate of BLA submission for HD201,” said Chief Executive Officer of Prestige Biopharma, Lisa Park.

“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.”

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.

More details at www.prestigebiopharma.com.

-- BERNAMA