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Biosimilars: approval

A biosimilar is a biologic product that is approved based on a demonstration that it is highly similar to an already-approved biologic product, known as the reference medicine1

The aim of biosimilar approval is to demonstrate high similarity in terms of structure, biological activity, efficacy, safety and immunogenicity1

By demonstrating biosimilarity, a biosimilar can rely on the safety and efficacy experience gained with the reference medicine, avoiding unnecessary repetition of prior clinical trials of the reference medicine1

If a biosimilar is highly similar to the reference medicine, and has comparable safety and efficacy in one indication, those data can be extrapolated to other indications already approved for the reference medicine1

Extrapolation is a well-established scientific principle used routinely when biologics with several approved indications undergo major changes to their manufacturing process1
  • Extrapolation is not automatic and must always be supported by scientific evidence generated in robust comparability studies1,2 
  • In most cases, clinical studies are not repeated for all indications and changes are approved based on quality and in vitro comparability studies1
  • However, sufficient scientific justification needs to be provided for extrapolating clinical data to support a determination of biosimilarity for each condition of use for which approval is sought1,2
Development and approval of a biosimilar progresses in a step-wise manner1HeaderKickerHeader of this CTA card goes here

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Please refer to the INFLECTRA® Summary of Product Characteristics for full prescribing information


EMA/European Commission. Biosimilars in the EU: information guide for healthcare professionals. 2019. Available at: Accessed May 2023.FDA. Scientific considerations in demonstrating biosimilarity to a reference product. April 2015. Available at: Accessed May 2023.
Clinical evidence

INFLECTRA® infusion therapy (CT-P13) has been evaluated across 5 randomised controlled trials

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