Genéricas

Genéricas refer to generic medicines in Portuguese-speaking contexts. These are medicines that contain the same active ingredient as a brand-name reference product and are manufactured and marketed after the reference product’s patent protection expires or after regulatory market-entry is allowed for generics. A generic medicine is expected to have the same dosage form, strength, route of administration, safety, efficacy, and quality as the original product. To be approved, generic medicines must demonstrate bioequivalence to the reference drug, meaning that they release the active ingredient into the bloodstream at a rate and extent that can be considered equivalent.

Regulatory oversight is provided by national health authorities and follows good manufacturing practices. Generics must meet standards for manufacturing quality, stability, and labeling. In many countries, the active ingredient name is used on packaging rather than the brand name, and substitutions by pharmacists may be permitted or required under policy or physician guidance, depending on the jurisdiction.

Economically, genéricas are designed to reduce costs for patients and health systems by introducing competition after patent expiration. This can improve access to essential medicines and reduce expenditure on medicines overall. However, perceptions of quality and variations in excipients may influence uptake in some markets.

Biosimilars, which are generics of biologic drugs, are not typically referred to as genéricas; instead they are described as biosimilares and are subject to additional analytical and clinical comparability requirements.