Generic medicine

A generic medicinal product is a medicinal product that has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as a reference medicinal product, and whose bioequivalence with it has been demonstrated by appropriate studies. This definition appears in the Public Health Code, which can be consulted on Légifrance, and in the European Directive on medicinal products for human use. The generic medicinal product is marketed at a lower price than the originator, after expiry of the protections the latter enjoys.

Authorisation and marketing of the generic medicinal product

First, the generic obtains a generic marketing authorisation through an abridged procedure referring to the dossier of the reference medicinal product, subject todata exclusivity. Next, in France, it is entered in the register of generic groups kept by the National Agency for the Safety of Medicines, which allows the pharmacist to substitute it for the prescribed originator, unless the prescriber states otherwise. Finally, its price and reimbursement are set according to rules that organise a discount compared with the originator and encourage substitution. The different salts, esters or isomers of the same active substance are considered the same substance, unless there is a significant difference in safety or efficacy.

The generic medicinal product and patents

The generic may only be lawfully marketed after expiry of the patent and the supplementary protection certificate covering the substance, or after their revocation. The trials and steps needed to obtain the marketing authorisation are, however, permitted during the life of the patent by theBolar exemption. Secondary patents, covering formulations, processes, salts or second medical uses, often outlive the patent on the molecule and are at the heart of litigation, the generic manufacturer contesting or working around them. Agreements between originators and generic manufacturers delaying market entry are examined by competition authorities as pay-for-delay agreements.

Key points

In practice, the arrival of a generic medicinal product is prepared years in advance, by the originator as well as the generic manufacturer: mapping of patents and certificates, timetable of regulatory exclusivities, oppositions and revocation actions, decision on a launch at risk. The firm acts in all these disputes, as presented on the page pharmaceutical patents and regulation.