Charles River delivers solutions for your biosimilar testing and manufacturing programs. A development program consisting of analytical and bioanalytical assays, pharmacology and/or toxicology studies in animals and clinical trials is required to show that biosimilars are highly similar to the reference biologic product. Our experience working with biologics across the drug development continuum, combined with our scientific and regulatory expertise, means we are an ideal partner for your biosimilar development.

Biosimilar Program Development

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Since the development and manufacturing of biosimilars can be just as complex as the innovator products, it is important to find a provider that has experience with various types of molecules.

Below are some of the molecules that Charles River has worked with:

  • Rituximab
  • Infliximab
  • Trastuzumab
  • Adalimumab
  • Erythropoietin
  • Pegfilgastrim
  • Filgastrim
  • Natalizumab
  • Teriparatide
  • Forsteo
  • Etanercept
  • Glatiramer Acetate
  • Bevacizumab

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Outsourcing Biosimilar Development

A rapid increase in the number of companies working on the development and registration of biosimilars has created a significant market for outsourced services specific to these products. Niall Dinwoodie from Charles River discusses this in BioProcess International.

ADCP: Improving Bioassay Reproducibility

In this BioProcessing Journal article, Dr. Ulrike Herbrand summarizes a number of challenges associated with ADCP assays and discusses how novel approaches are more reliable in measuring this neglected MOA.

Setting a Precedent for Biosimilars in the U.S.

Niall Dinwoodie, Global Coordinator of Biologics Testing Solutions, sat down with Contract Pharma to discuss his insights regarding biosimilar industry issues and the development process in regards to regulatory hurdles.