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 regulatory expertise, means we are an ideal partner for your biosimilar development.

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Experts elaborate on aspects of biosimilar development including potency determination, structural characterization and bioanalytical assay requirements. Register »

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 examples of molecules that Charles River has worked with:

Hormones: Erythropoietin, Teriparatide, Parathyroid hormone
Cytokines: Pegfilgrastim, Filgrastim, Molgramostim
mAbs:

Other: Etanercept

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