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Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act

Assessing biosimilarity and interchangeability of biosimilar products under the Biologics Price Competition and Innovation Act

Biological (large molecule) drug products are made via living systems and are complex and variable in nature.As a result, generic forms of biological products, also termed biosimilars in the EU or follow-on biologics by the US Food and Drug Administration, can only be similar to the reference product, unlike generic …