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Insights into Biosimilar Development

Charles River has established a portfolio of offerings for biosimilars that spans across the development continuum. From structural assays to nonclinical and clinical laboratory support packages, we are able to provide clients a fully integrated solution. Our scientists not only have experience with the technical aspects of biosimilar characterization, safety and comparability studies but also are able to help clients navigate through the regulatory guidelines and make recommendations as to what should and should not be included in studies being performed. Our knowledge gained by working with both originator and biosimilar molecules makes us a unique resource for our clients. Two recent articles featured in BioProcess International give insights into how companies continue to turn to CROs and other outsourcing venues for support and guidance in their biosimilar development efforts. Also discussed are regulatory guidelines that are driving the approaches to how testing programs are executed.

Visit our biosimilars webpage for more resources around biosimilar development and how Charles River can partner with you in this process. To discuss your program with our scientists contact us at [email protected].