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A biosimilar is a biological medicine that is highly similar to another biological medicine (reference medicinal product) which already has a marketing authorisation and has been approved for use in patients. As such, biosimilars contain a version of the active substance of an approved biological medicine and generally should be used in the same way for its own approved indications.
The purpose of this guidance is to explain the regulatory assessment process that is mandated in medicines legislation for the authorisation of biosimilar medicines. The guidance covers a range of topics relevant to this, including explanations of the differences between a ’reference biological medicine’ and a ‘biosimilar medicine’, differences between biosimilar medicines and ’small molecule’ generic medicines’; the requirements for biosimilars to achieve marketing authorisation (regulatory approval) and how this takes account of the specific nature of these medicines. The guidance also discusses issues surrounding the prescribing, dispensing, interchangeability and pharmacovigilance of biosimilars in the context of the Irish market place.
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