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Capabilities to Support the Development and Commercialization of Biosimilars

August 23, 2010 - As patent protections for successfully marketed biopharmaceuticals continue to expire, the door has opened for the development of biosimilar products. Multiple biosimilars have entered European and other markets, and the US FDA is now developing guidance and a regulatory review process.

Charles River’s involvement in the CMC (including lot release), preclinical pharmacology and toxicology studies, and clinical trials of biological products extends over 20 years. Our comprehensive international experience associated with the development of biological products means that Charles River understands the complexities involved and can apply this knowledge to the development of biosimilars.

Our capabilities include:

  • Quality, safety and release testing - including in vitro bioassays
  • Pharmacology and toxicology studies to demonstrate biosimilarity
  • Bioanalytical expertise for developing assays for pharmacokinetics and immunogenicity
  • Clinical pharmacology studies in healthy volunteers and patients
  • Regulatory experience and guidance with biosimilars program development


For more information about our capabilities to support biosimilars, please contact us at askcharlesriver@crl.com.

 

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For more information, contact us at:

1.877.CRIVER.1 (1.877.274.8371)
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