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ARTICLE · 24 FEBRUARY 2026

An IP Guide To Biosimilars

Boult Wade Tennant LLP
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A biosimilar is defined by the European Medicines Agency (EMA) as: "a biological medicine highly similar to another biological medicine already approved in the EU...

United KingdomIntellectual Property
Nadia Tyler-Rubinstein
Nadia Tyler-Rubinstein
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A biosimilar is defined by the European Medicines Agency (EMA) as: "a biological medicine highly similar to another biological medicine already approved in the EU (called 'reference medicine') in terms of structure, biological activity and efficacy, safety and immunogenicity profile".

Developers of biosimilars are required to demonstrate through comprehensive comparability studies with the 'reference' biological medicine that their biological medicine is highly similar to the reference medicine, notwithstanding natural variability inherent to all biological medicines, and that there are no clinically meaningful differences. Consequently, biosimilar developers can benefit to some extent from the work carried out by the original innovator company, for instance by avoiding unnecessary repetition of clinical trials already carried out with the reference medicine. This streamlined approval process should increase competition, enabling biosimilar alternatives to enter

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