Biosimilar Solutions Initiates Registrational Clinical Trial for Biosimilar Version Neulasta
Apr 13, 2022
OcyonBio, LLC's client Biosimilar Solutions, Inc., announces it has started its registrational clinical trials for the biosimilar version of Neulasta Filgrastim, a granulocyte-colony stimulating factor (PEG-GCSF). BSC0826 is a recombinant filgrastim product tested for biosimilarity with its reference product, Neupogen®.
Pegfilgrastim is in a class of medications called colony-stimulating factors. PEG-GCSF works by helping the body make more neutrophils, a type of white blood cell (leukocytes) that acts as your immune system's first line of defense. PEG-GCSF (NEULASTA) injection products reduce the chance of infection in patients with certain cancer types who receive chemotherapy medications that decrease the number of neutrophils. The drug also increases the chance of survival in people exposed to harmful amounts of radiation, which can cause severe and life-threatening damage to the bone marrow.
Daniel Chang, co-founder of Biosimilar Solutions, said, "We are excited to initiate our second registrational study for BSC0826. Biosimilar product development poses a number of scientific, regulatory, and technical challenges that distinguish it from traditional, small-molecule generic product development. Our team includes industry veterans with decades of experience in pioneering biologics companies, such as Amgen and Genentech, where they 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."
The design of the clinical trials was reviewed and approved by the FDA. Biosimilar Solutions, Inc. has signed a long-term collaboration manufacturing and operations agreement with OcyonBio and has plans to complete a technology transfer in 2022 and a product launch in 2023.
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. These companies 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.
CONTACT
Name: Daniel Mora
Phone: 1-646-480-0356
Email: [email protected]
Press Release Service by Newswire.com
Original Source: Biosimilar Solutions Initiates Registrational Clinical Trial for Biosimilar Version Neulasta
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