OcyonBio Client Biosimilar Solutions, Inc. Initiates Registrational Clinical Trial for Its First Biosimilar Product
Biosimilar Solutions, Inc. expects to complete the clinical study in 2022
AGUADILLA, Puerto Rico, March 23, 2022 (GLOBE NEWSWIRE) — Biosimilar Solutions, Inc. announces it has started its registrational clinical trials for BSC1020®, a recombinant filgrastim product tested for biosimilarity with its reference product, Neupogen®. The design of the clinical trials was reviewed and approved by FDA and is planned to be completed in July 2022.
Neupogen® (filgrastim) is a drug that has been used successfully for cancer patients to stimulate the growth of the white blood cells, making patients less vulnerable to infections, it is expected to help patients who have bone marrow damage from very high doses of radiation in much the same way.
Intensive chemotherapy in cancer patients can cause neutropenic fever and infection, which delays chemotherapy cycles and increases mortality and morbidity of chemotherapy-treated patients. Neupogen® is the first commercial pharmaceutical analog of G-CSF from Amgen Inc. and is manufactured at Amgen’s Biologics facility in Puerto Rico. It has been a great success since its first approval in 1998 and is still among the top 15 best-selling drugs of 2022
This trial commenced in February and will complete in the summer of 2022. The clinical trial is designed to determine the similarity between the biosimilar and the reference product. Biosimilar Solutions, Inc. has recently signed a long-term collaboration manufacturing and operations agreement with OcyonBio, LLC and has plans to complete a technology transfer to begin manufacturing in Puerto Rico in 2022.
Daniel Chang, co-founder of Biosimilar Solutions said, “We are excited to initiate our first registrational study for BSC1020. We are confident in our CDMO OcyonBio and Puerto Rico’s role as a global center for pharmaceutical innovation, manufacturing, and distribution. Biosimilars complement our mission to provide affordable medicine to the world. Our goal is to transfer one biologic from India per year for approval by the US FDA.
The company will leverage access to skilled talent, government incentives and other assets to establish world-class facilities dedicated to the research, development and manufacture of biosimilar therapies. Through its operations, Biosimilar Solutions, Inc. strengthens Puerto Rico’s role as a global center for pharmaceutical innovation, manufacturing and distribution.
About OcyonBio, LLC
OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements. OcyonBio provides a company with its own space, so there is no need to build an expensive facility. Providing flexibility to protect IP, manage schedules, resources, and new product introduction reducing overall cost and risks.
About Biosimilar Solutions, Inc.
Biosimilar Solutions is a leading biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets, lasered focus on affordability, increasing patient access with Uncompromising Quality. Biosimilar product development poses a number of scientific, regulatory and technical challenges that distinguish it from traditional, small-molecule generic product development. We believe our world-class team of biologic therapeutic developers and renowned scientists gives us the critical capabilities to successfully address the complexities underlying these challenges. Our team includes industry veterans with decades of experience in pioneering biologics companies, such as Amgen and Genentech, where they were responsible for leading, and in some cases establishing, these organizations’ core capabilities in process development, protein manufacturing and analytical research and development. Senior members of our internal team have contributed to the filing of over 100 Investigational New Drug applications, or INDs, and over 40 marketing applications, including those for Enbrel, the originator product for our lead biosimilar product candidate. We have also assembled a distinguished Scientific Advisory Board of leading scientists who are acknowledged experts in their respective fields.
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