Biosimilar medicinal product

A biosimilar is a biological medicinal product similar to a reference biological medicinal product that has already been authorised. It is not identical to it, since a biological medicinal product is produced by living organisms and exhibits natural variability. The biosimilar thus differs from the generic, which is the exact chemical copy of a synthetic active ingredient.

Authorisation of the biosimilar

A biosimilar obtains a marketing authorisation through a specific procedure. The applicant must demonstrate similarity with the reference product in terms of quality, safety and efficacy, through comparative studies. However, it does not have to reproduce the entire clinical dossier of the reference product. In Europe, the European Medicines Agency centralises these authorisations. The biosimilar therefore reaches the market after the expiry of the data protection period of the reference product.

Biosimilars and patents

A biological medicinal product is protected by a set of patents: a product patent on the protein or antibody, process patents on the cell lines and production steps, formulation patents and indication patents. Likewise, a supplementary protection certificate may extend the protection of the active ingredient. The biosimilar manufacturer must therefore map these titles and assess their validity before any launch.

Biosimilar litigation

Litigation frequently concerns process patents, whose infringement is difficult to prove without access to the competitor's facilities. In practice, the saisie-contrefaçon and the evidence preservation measures before the Unified Patent Court play a central role. By contrast, theBolar exemption allows the trials needed to obtain the authorisation without infringement.

The firm acts for reference laboratories and biosimilar manufacturers, on validity, infringement and provisional measures. See our page pharmaceutical patents and regulation and the information of theEuropean Medicines Agency.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats litigates patent disputes before the Paris Judicial Court, the Paris Court of Appeal and the Unified Patent Court. Where the question arises in a real case, the useful moment is almost always before proceedings are issued.

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