Biosimilars Development and Testing Services | Charles River

biosimilars 

On February 9, 2012, almost 3 years after the Biologics Price Competition and Innovation Act (BPCIA) of 2009 amended section 351(k) of the Public Health Service (PHS) Act to create a legal pathway for biosimilars in the US, the FDA published the series of draft guidance documents listed below to define their recommendations for biosimilars development. These draft documents are open for comment for 60 days from the publication date. The final documents are likely to differ from the drafts.

Scientific Considerations in Demonstrating Biosimilarity to a Reference Product

Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product

Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009Charles River experts have reviewed these documents and identified the main points that impact our clients. Click here for more information. 


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 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. 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


Related Information
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

For more information about our capabilities to help support the development and commercialization of biosimilars, contact us at 1.877.CRIVER.1 or askcharlesriver@crl.com.

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1.877.CRIVER.1 (1.877.274.8371)
askcharlesriver@crl.com

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