Génériques

Génériques are medicines that contain the same active ingredient as a referenced brand-name product and are marketed at a lower price once the original patent protection and data protections expire. They are intended to be interchangeable with the reference medicine in terms of dosage, strength, route of administration and intended use.

To be approved, génériques must demonstrate bioequivalence to the reference product, meaning they deliver the active substance into the bloodstream at a similar rate and extent. They may differ in inert ingredients, color or packaging, but must meet the same standards of quality, safety and efficacy as the originator. They are typically labeled with the international nonproprietary name of the active ingredient and do not bear the brand name of the reference product.

Regulatory pathways for génériques vary by country. In the European Union, marketing authorization is granted after demonstrating bioequivalence and quality. In the United States, manufacturers apply via an abbreviated new drug application. Across jurisdictions, regulatory agencies monitor manufacturing practices and post-market safety.

Economically, génériques increase competition and generally reduce therapy costs, improving patient access. Substitution policies vary: pharmacists may substitute a prescribed brand with a medically appropriate generic unless the prescriber or patient specifies otherwise. Public and private payers often encourage generic use through pricing and formulary decisions.

A note on terminology: génériques typically refer to small-molecule medicines. For biologic medicines, the term biosimilar is used instead of generic, since exact copies are harder to achieve due to the complexity of biological products. Nonetheless, génériques play a central role in health systems by sustaining access to essential medicines while containing costs.