Biological medicinal product

A biological medicinal product is a medicinal product whose active substance is produced by or extracted from a biological source and for whose characterisation and quality determination a combination of physico-chemical and biological testing, together with knowledge of the production process and its control, is needed. This definition appears in Annex I to Directive 2001/83/EC and is reproduced in Article L. 5121-1 of the French Public Health Code. Vaccines, medicinal products derived from blood, recombinant proteins, monoclonal antibodies and advanced therapy medicinal products fall within it.

The authorisation regime

Medicinal products developed by biotechnological processes, in particular recombinant DNA technology or hybridoma and monoclonal antibody methods, must be authorised through the centralised procedure under the Annex to Regulation (EC) No 726/2004. The variability inherent in living organisms explains why the process determines the quality of the product. Any change to the manufacturing process therefore requires a comparability exercise, and recording of the name and batch number is required for pharmacovigilance purposes.

Copies of biological medicinal products

A copy of a biological medicinal product cannot be shown to be identical to its model. It follows the biosimilar route, which requires a demonstration of similarity in quality, safety and efficacy through comparative studies more demanding than the mere bioequivalence required of a generic. Regulatory data protection for the reference is subject to the same periods as for chemical medicinal products. In France, pharmacist substitution is governed by specific rules, discussed under interchangeability of biosimilars.

Patent protection

The portfolio of a biological medicinal product most often combines a product patent on the protein or antibody, process patents on cell lines, culture and purification, formulation patents and use or dosage regimen patents. Antibody claims defined by their function or target give rise to lively debate on sufficiency of disclosure. Protection of a process extends to the product directly obtained by it, which makes it possible to take action against the import of a biosimilar manufactured outside Europe, provided that the process used can be proved.

Key points

A biological medicinal product is defined by its origin and by the decisive role of its manufacturing process. The consequences should be drawn in both advisory work and litigation, by protecting and monitoring the process as much as the product. For a biosimilar manufacturer, the freedom-to-operate study must cover process and formulation patents, which often run later than the product patent.

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

Dhenne Avocats acts in pharmaceutical patent disputes and on the medicines regulatory questions that accompany them, from the marketing authorisation to the supplementary protection certificate.

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