Intercambiabilidad de medicamentos de origen biológico (biofármacos): Consideraciones acerca de la aprobación de formulaciones biosimilares (biogenéricos) en Chile

S, Iván Saavedra; S, Luis Quiñones

doi:10.4067/s0034-98872006001200015

Cited by 4 publications

(5 citation statements)

References 8 publications

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“…In 2006, Saavedra and Quiñones 94 described considerations pertaining to the interchangeability of BPs and the approval of SBPs in Chile. The authors stated that the Public Health Institute and the Ministry of Health of Chile must consider that for BPs there are no interchangeable generics, and must also consider that the bioequivalence of these medications should be addressed on a case-by-case basis following nonclinical and clinical studies that can demonstrate efficacy and safety.…”

Section: Chilementioning

confidence: 99%

“…The authors stated that the Public Health Institute and the Ministry of Health of Chile must consider that for BPs there are no interchangeable generics, and must also consider that the bioequivalence of these medications should be addressed on a case-by-case basis following nonclinical and clinical studies that can demonstrate efficacy and safety. 94 In 2010, the Chilean Society of Rheumatology issued a statement on the authorization of SBPs, supporting their development based on the patient's right to have better access to appropriate and timely treatment. 95 The concerns of these two articles mentioned 94,95 were solved by the current Chilean guidelines on SBPs.…”

Section: Chilementioning

confidence: 99%

“…94 In 2010, the Chilean Society of Rheumatology issued a statement on the authorization of SBPs, supporting their development based on the patient's right to have better access to appropriate and timely treatment. 95 The concerns of these two articles mentioned 94,95 were solved by the current Chilean guidelines on SBPs. 57 …”

Section: Chilementioning

confidence: 99%

See 2 more Smart Citations

Similar biotherapeutic products in Latin America. Regulation and opportunities for patients with autoimmune diseases

Desanvicente-Celis¹,

Caro-Moreno²,

Enciso-Zuluaga³

et al. 2013

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Biotherapeutic products have revolutionized medicine, changing the way we can treat some chronic diseases, such as autoimmune diseases. The patent expiry and the high costs of reference biotherapeutic products, among other factors, have promoted interest in similar biotherapeutic products (SBPs), also known as biosimilars. The objective of developing an SBP is to manufacture a "highly similar" molecule to a reference biotherapeutic product, by conducting a comparability exercise that can demonstrate similar quality, safety, and efficacy. Regulations like those of the World Health Organization, the European Medicines Agency, and the Food and Drug Administration are international reference standards. Herein, we aim to point out the current status in Latin America on SBPs, focusing on regulatory issues within the context of autoimmune diseases. The regulations of Argentina, Peru, Chile, Guatemala, Panama and Costa Rica follow the World Health Organization guidelines. Other countries, such as Cuba, Mexico, Venezuela, and Brazil have regulations that take into account international standards combined with local features. In Colombia, a draft decree is under revision and the debate is ongoing. Some countries have already approved SBPs. Mexico, Chile, Ecuador, Bolivia, and Peru market SBPs of rituximab, and Colombia markets an SBP of etanercept. The advent of SBPs is definitely beneficial. Safety and efficacy must be ensured following clear and comprehensive regulations.

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Section: Chilementioning

confidence: 99%

Section: Chilementioning

confidence: 99%

See 1 more Smart Citation

Similar biotherapeutic products in Latin America. Regulation and opportunities for patients with autoimmune diseases

Desanvicente-Celis¹,

Caro-Moreno²,

Enciso-Zuluaga³

et al. 2013

View full text Add to dashboard Cite

show abstract

“…All products were required to provide the full complement of clinical studies to gain registration, as they considered that the similar drugs available had a different chemical composition because they were manufactured through different processes [11]. In 2011, Chile's Agencia Nacional de Medicamentos (ANAMED) released draft guidance for the evaluation of biosimilars.…”

Section: Chilementioning

confidence: 99%

“…Therefore, the approval of biosimilar products requires the performance of pharmacokinetic, preclinical and clinical analytical studies, such as physicochemical assays, biological and immunological tests. These issues have been established by WHO, and have been incorporated into the main drug registry entities worldwide [11]. In addition, it is essential to implement a pharmacovigilance system after product commercialization, so that safety and effi cacy of biosimilar products can be evaluated [10].…”

Section: Biosimilars Development In Latin American Countriesmentioning

confidence: 99%

Biosimilarity in Latin America

Chiann¹

2013

GaBI J

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Recommendations on how to ensure the safety and effectiveness of biosimilars in Latin America: a point of view

Pineda

Caballero-Uribe

Oliveira³

et al. 2015

Clin Rheumatol

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The use of biotechnology-derived medicines has significantly increased in recent decades. Although biosimilars undergo rigorous characterization as well as clinical studies to document their safety and effectiveness, they are highly complex molecules and small changes in the purification and production process of a biosimilar can have major implications in its safety and effectiveness profile. In Latin America, regulatory authorities have begun to establish well-described and standardized pathways that permit a biosimilar to gain commercial licensure. In order to be certain that a biosimilar reaches its potential in ordinary clinical use, an intensive post-licensing monitoring system must be established since it is the only means to ascertain the true similarity between the original biologic and its biosimilar. Pharmacovigilance allows national authorities to determine a drug’s performance in the marketplace. An effective tracking and pharmacovigilance system for biological medicines has many steps and processes. To aid policy makers in Latin American in addressing the many issues surrounding the establishment of an effective pharmacovigilance system, the Americas Health Foundation convened a group of experts to discuss the topic and develop recommendations for implementation. The group discussed current challenges and gaps in pharmacovigilance in Latin America, paying close attention to the major issues associated with traceability and pharmacovigilance of biosimilars following their approval. The recommendations developed should enable countries to accurately document the safety and performance of a biosimilar as experienced by patients under real-life conditions and have a significant impact on the successful implementation of pharmacovigilance of biosimilars throughout the region.

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Intercambiabilidad de medicamentos de origen biológico (biofármacos): Consideraciones acerca de la aprobación de formulaciones biosimilares (biogenéricos) en Chile

Cited by 4 publications

References 8 publications

Similar biotherapeutic products in Latin America. Regulation and opportunities for patients with autoimmune diseases

Similar biotherapeutic products in Latin America. Regulation and opportunities for patients with autoimmune diseases

Biosimilarity in Latin America

Recommendations on how to ensure the safety and effectiveness of biosimilars in Latin America: a point of view

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