Prestige Biopharma said Wednesday that the dosing of its Avastin biosimilar, HD204, conducted by global contract research organization (CRO) IQVIA, will be completed this month.

HD204 (Courtesy of Prestige Biopharma)
HD204 (Courtesy of Prestige Biopharma)

HD204 is being studied in a global phase 3 clinical trial by two leading CROs, enrolling 650 patients in 17 countries worldwide. The other contractor, Cromos Pharma, also expects dosing to be completed soon.

Accordingly, Accord Healthcare, which handles the marketing authorization for HD204, will begin preparations for commercialization this year.

In 2022, Prestige Biopharma signed a license and supply agreement with multinational pharmaceutical giant Intas for Avastin biosimilar HD204 covering major markets around the world, including Europe, the United States, the United Kingdom, Canada, Brazil, Mexico, the Middle East and North Africa (MENA), and Southeast Asian countries.

Prestige Biopharma intends to accelerate the commercialization of HD204. The company will continue to analyze the results with IQVIA and work closely with Accord Healthcare, a subsidiary of Intas, to speed up the commercialization of HD204.

"HD204 is already showing positive results in more than 600 patients," said an official Prestige Biopharma's RMA team. "We plan to complete dosing of the remaining patients as soon as possible and continue to work closely with our clinical contract research organizations and regulatory authorities to accelerate commercialization."

 

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