A biosimilar product is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved innovator product.
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A biosimilar product is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved innovator product.
Biosimilar manufacturer must show that the biosimilar product is highly similar to the innovator product by extensively characterizing the structure, function and bioactivity of the reference standard, innovator product and biosimilar product. Based on the comprehensive test results along with other information (such as clinical studies), minor differences between the innovator product and biosimilar product, clinically inactive components such as stabilizers or buffers are acceptable. Any differences between the biosimilar and the innovator product need to be carefully evaluated by FDA to ensure the biosimilar product meets regulatory standards.
Characterization of the reference standard, innovator product and biosimilar product includes testing on the following attributes:
Purity
Chemical identity
Bioactivity
Our programs are tailored to meet the ICH Q6B guidelines, incorporating a variety of analytical techniques as well as information covering a number of features, including physicochemical property determination, structural analysis, post-translational analysis, and determination of biological potency. We also utilize a range of mass spectrometry, chromatographic, and other analytical techniques to identify process and product-related impurity profiles.
The diverse nature of our services, combined with the experience of our highly motivated and experienced scientists provides valuable information to support our clients throughout the development and manufacturing process of biosimilar products.