Biosimilarity in Latin America

Chiann, Chang

doi:10.5639/gabij.2013.0202.021

Cited by 3 publications

(2 citation statements)

References 11 publications

(19 reference statements)

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“…However, on 16 th December 2010, Brazil has issued guidelines for biosimilars based on the different regulations and documents all around the world, including Health Canada, EMA, KFDA, and WHO, although it mainly follows WHO Similar Biological Product Guidelines [87]. The similarities are regarding the use of a reference product based on a suitable period of market use and the demonstration of sufficient scientific information on quality, efficacy and safety, as well as the need for specific pharmacovigilance.…”

Section: Brazilmentioning

confidence: 99%

Chronotherapeutics: A Novel Approach in the Pharmacotherapy of Various Diseases

Patil¹

2016

J Pharmacovigil

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Section: Brazilmentioning

confidence: 99%

Chronotherapeutics: A Novel Approach in the Pharmacotherapy of Various Diseases

Patil¹

2016

J Pharmacovigil

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“…Biosimilars are considered interchangeable if a therapeutically equivalent biologic can be prescribed by a physician in place of its reference product [ 15 , 16 ]. According to the FDA’s Biologics Price Competition and Innovation Act (BPCIA), “to meet a higher standard of “interchangeability,” an applicant must provide sufficient information to demonstrate biosimilarity, and also to demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient and, if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch..”…”

Section: Substitutionmentioning

confidence: 99%

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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Biosimilars: An Approach to some Current Worldwide Regulation Frameworks

Esteban

Bustos

Casallas

et al. 2019

CCP

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Developing new biologics has led to regulations and norms aimed at guaranteeing their safety, quality and effectiveness, in terms of marketing, prescription, use, interchangeability and switching. Biologics are of great importance in treating patients suffering from rheumatic, autoimmune, inflammatory and neoplastic diseases. The expiry/lapse of reference biologics or originators’ patents has meant that developing biosimilars involves accompanying legal requirements for their approval in countries worldwide. This paper has thus approached the situation of biosimilar regulation worldwide, the pertinent technical concepts and regulatory differences in some countries of interest.

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Biosimilarity in Latin America

Cited by 3 publications

References 11 publications

Chronotherapeutics: A Novel Approach in the Pharmacotherapy of Various Diseases

Chronotherapeutics: A Novel Approach in the Pharmacotherapy of Various Diseases

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

Biosimilars: An Approach to some Current Worldwide Regulation Frameworks

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