Biosimilar Solutions, Inc. expects to complete the clinical study in 2022
Wednesday, March 23, 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.
Monday, March 14, 2022
AGUADILLA, Puerto Rico, (Newswire.com) – OcyonBio announces manufacturing and operations agreement to develop biosimilar drug product facilities for Biosimilar Sciences PR, LLC, Inc. OcyonBio is creating an advanced therapy contract development, manufacturing organization (CDMO) that provides pre-clinical through commercial manufacturing including process development, plasmid DNA, viral vectors, cell banking, cell processing, and supporting testing capabilities.
“With our partnership development manufacturing organization model, OcyonBio is the perfect partner to usher in these biosimilars to the U.S. Biosimilar Solutions, Inc. will have streamlined control over cGMP production in a facility that has been designed to meet global regulatory expectations and readiness for FDA, EMA, and global regulatory audits,” said Robert Salcedo, CEO of OcyonBio.
Biosimilar Sciences PR LLC is pleased to announce its strategic partnership with Ocyonbio, engaging their state-of-the-art CDMO (Contract Development and Manufacturing Organization) services to advance the commercialization of its biosimilar molecule across the North American territory, including the United States, Canada, and Mexico.
This collaboration marks a significant milestone, as the biosimilar molecule — licensed from a reputed and globally recognized development partner based in India — moves closer to bringing high-quality, affordable therapeutic solutions to patients across the region. By leveraging Ocyonbio’s robust infrastructure and technical expertise, Biosimilar Sciences PR LLC is poised to ensure efficient, compliant, and scalable manufacturing in alignment with regulatory standards.
Biosimilar Sciences PR LLC operates its own subsidiary in India, staffed with a dedicated team of experienced scientists, regulatory specialists, CMC experts, and quality control professionals. This in-house capability enables the company to efficiently manage the development and clinical operations of its biosimilar molecules, ensuring high standards of quality, compliance, and scientific excellence throughout the product lifecycle.
