Charles River delivers client-focused solutions for the specific testing and manufacturing requirements of your biosimilars. Biosimilars, like the reference biologic products, are complex protein structures that are difficult to characterize. Therefore, a biosimilars development program consisting of analytical and bioanalytical assays, pharmacology and/or toxicology studies in animals and clinical trials are required to show that biosimilars are highly similar to the reference biologic product. Biosimilar production processes are highly complex, expensive and can be difficult to control, so it is essential to work with a provider that can perform the full development program while providing the control essential to product uniformity. Our experience working with biologics across the drug development continuum, together with our scientific and regulatory expertise, makes Charles River an ideal partner for your biosimilar development.
Capabilities to Support Development and Commercialization of Biosimilars
Webinar Replay: Trends and Challenges in the Development and Registration of Biosimilars (April 2010)
Webinar Replay: Preclinical Development of Biosimilars (March 2011)
Datasheet: Development and Testing Services for the Commercialization of Biosimilars
Biosimilars Regulatory Library
For more information about our capabilities to help support the development and commercialization of biosimilars, contact us at 1.877.CRIVER.1 or firstname.lastname@example.org.