Biosimilar Solutions Initiates Registrational Clinical Trial for Biosimilar Version Neulasta OcyonBio
Biosimilar Solutions, Inc. will set up a facility in Aguadilla in OcyonBio’s Campus in Puerto Rico to support the production of BSC0826.
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AGUADILLA, Puerto Rico, April 13, 2022 (GLOBE NEWSWIRE) — 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.
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