Search results for BPCIA

US interchangeability designation: are we ready to cut the Gordian knot?

Author byline as per print journal: Joseph P Park1, PhD; Gillian R Woollett2, MA, DPhil Abstract: US Food and Drug Administration’s (FDA) current thinking on interchangeability has evolved since the legal designation was first created in 2010. Based on experience, FDA now acknowledges that clinical switching studies are not generally needed for the interchangeability designation […]

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

Author byline as per print journal: Professor Shein-Chung Chow, PhD, Christine Ju, MSc Abstract: 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 […]

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