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.
The Future of Biosimilar Gene Therapies: Key Issues and Potential
September 11th 2024While biosimilars could potentially lower costs and improve access to gene therapies, significant hurdles in regulation, manufacturing, intellectual property, and market size pose challenges to their development and market entry.
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.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: FDA Opens Up Biosimilar Inquiries on Reddit
August 26th 2024Sarfaraz K. Niazi, PhD, urges stakeholders to engage with the FDA on its Reddit forum—where a representative will answer complex biosimilar questions—encourages clearing misconceptions, and advocates for updates to the Biologics Price Competition and Innovation Act guidelines.
CMS Announces New Drug Prices Under the IRA, Including for Stelara and Enbrel
August 19th 2024CMS announced negotiated prices for 10 drugs under the Inflation Reduction Act (IRA), sparking mixed reactions, with concerns that including drugs facing imminent biosimilar competition could hinder market access to lower-cost alternatives.