Russia's land area is vast relative to its population, but Prestige Biopharma eyes an ample market for its bevacizumab biosimilar candidate (HD204).
Russian pharmaceutical company Pharmapark has obtained the Russian distribution rights for a bevacizumab biosimilar candidate (HD204) developed by Singapore company Prestige BioPharma.
Bevacizumab is a monoclonal antibody used in the treatment of multiple forms of cancer including metastatic colorectal cancer, advanced non–small cell lung cancer, kidney cancer, and epithelial and cervical cancers. The biosimilar references Avastin, a Roche product.
HD204 is currently undergoing a phase 3 clinical development trial (SAMSON-II) for safety and efficacy. Prestige BioPharma previously reported positive pharmacokinetic, safety, and immunogenicity results based on a phase 1 trial (SAMSON-1).
The commercialization deal encompasses distribution rights throughout Russia (aka Russian Federation), which has a population of 146 million and extends from Eastern Europe to Northern Asia. Prestige BioPharma will produce the biosimilar at its factory in Osong, Republic of Korea.
This is not the first collaboration between these 2 companies. In July 2019 they reached an agreement for the distribution of Prestige BioPharma’s trastuzumab candidate biosimilar (HD201), referencing Herceptin. HD201 is under review with the European Medicines Agency with a projected market launch in 2021.
“We are very pleased to further extend our partnership with Pharmapark to commercialize our second biosimilar program in the Russian Federation,” said Lisa S. Park, CEO of Prestige BioPharma, in a statement.
Prestige BioPharma also has an adalimumab biosimilar (PBP1502) in phase 1 development, and beyond biosimilars, the company is in early stage development of an anti–pancreatic adenocarcinoma up-regulated factor antibody (PBP1510) for pancreatic cancer and an anti–collagen triple helix repeat-containing protein antibody (PBP1710) for solid tumors.
For more about Prestige BioPharma’s commercialization plans for HD201, click here.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilars Oncology Roundup for June 2024—Podcast Edition
July 7th 2024On this episode of Not So Different, we review biosimilar news coming out of June, with clinical trial results from conferences and a study showcasing how to overcome economic and noneconomic barriers to oncology biosimilars.
Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements
February 25th 2025The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.