Percepção de uma comunidade acadêmica das diferenças entre medicamentos de referência e genéricos / An academic community's perception of the differences between reference and generic drugs

Soares, Francielen Souto; Souza, Leonardo Oliveira; Ruas, Luis Paulo Ribeiro; Andrade, Valéria Farias; Guimarães, Talita Antunes; Pinheiro, Thaisa de Almeida; Figueiredo, Flávio Júnior Barbosa; Pinheiro, Thales de Almeida

doi:10.34119/bjhrv4n3-187

Cited by 1 publication

(1 citation statement)

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“…However, using biowaivers is essential to ensure that generic medicine's quality, safety, and efficacy are not compromised. ANVISA has established strict standards for approving generic drugs, including those with biowaivers, to ensure the safety and efficacy of drugs available on the Brazilian market (Soares, F. S., 2021).…”

Section: Brazilmentioning

confidence: 99%

Knowledge-based: facilitating access to medicines in Latin America

Ferreira,

Pauletti,

Fernandes

et al. 2024

Braz. J. Hea. Rev.

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The World Health Organization (WHO), with the scientific support of the International Pharmaceutical Federation (FIP), guides the development of multisource pharmaceutical products for market authorization using in vivo bioequivalence studies or, where applicable, in vitro biowaiver strategies based on the Biopharmaceutical Classification System (BCS). A review of the regulatory framework guiding generic medicines approval in Latin American countries revealed that less than 50% of regional health authorities offer a generic medicines development pathway utilizing a BCS-based biowaiver strategy. Aligned with the ONE FIP Strategy to facilitate access to medicines, a regional case study was carried out to implement and harmonize BCS-based biowaiver knowledge in Latin American countries. A steering committee involving regional representatives from health authorities, the pharmaceutical industry, and universities were established to coordinate to develop activities. A series of digital engagement events were held in Spanish and English with representatives from Latin America to share knowledge on BCS-based regulatory strategy, promote collaborations, and explore the alignment of biowaiver approval and regulatory pathways among Latin American countries. Feedback from diverse Latin American stakeholders demonstrated inconsistent implementation of bioequivalence testing within the region. However, there is support for a synergistic approach among countries to reduce duplication and increase efficiency in market authorization for generic medicines. This includes alignment with the WHO Prequalification of Medicines program as well as the development of a computational database for the classification of active pharmaceutical ingredients to demonstrate therapeutic interchangeability of immediate-release oral dosage forms according to the BCS. FIP-facilitated digital learning opportunities raised awareness of the BCS-based biowaiver regulatory strategy among Latin American stakeholders. It resulted in a plan to continually strengthen collaborative efforts in the region to harmonize regulations relevant to drug development generics medicines to introduce cost-effective medicines products that benefit public health.

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Section: Brazilmentioning

confidence: 99%