Nonbioequivalent prescription drug interchangeability, concerns on patient safety and drug market dynamics in Brazil

Paumgartten, Francisco José Roma; Oliveira, Ana Raquel Soares de

doi:10.1590/1413-81232017228.04352017

Cited by 1 publication

(1 citation statement)

References 17 publications

(24 reference statements)

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“…The Brazilian health regulatory agency, Agência Nacional de Vigilância Sanitária (ANVISA), follows similar guidelines to interchangeability as that of the European Medicines Agency (EMA) [115]. While guidelines in the US connects interchangeability to substitution within pharmaceutical practice, interchangeability in Brazil constitutes medical practice within the scope of influence of physicians, patients, and Ministry of Health.…”

Section: Critical Challenges Of Biologics and Biosimilarsmentioning

confidence: 99%

The Breakthrough of Biosimilars: A Twist in the Narrative of Biological Therapy

2019

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The coming wave of patent expiries of first generation commercialized biotherapeutical drugs has seen the global market open its doors to close copies of these products. These near perfect substitutes, which are termed as “biosimilars”, do not need to undergo intense clinical trials for their approval. However, they are mandated to produce identical similarity from their reference biologics in terms of clinical safety and efficacy. As such, these biosimilar products promise to foster unprecedented access to a wide range of life-saving biologics. However, seeing this promise be fulfilled requires the development of biosimilars to be augmented with product trust, predictable regulatory frameworks, and sustainable policies. It is vital for healthcare and marketing professionals to understand the critical challenges surrounding biosimilar use and implement informed clinical and commercial decisions. A proper framework of pharmacovigilance, education, and scientific exchange for biologics and biosimilars would ensure a dramatic rise in healthcare access and market sustainability. This paper seeks to collate and review all relevant published intelligence of the health and business potential of biosimilars. In doing so, it provides a visualization of the essential steps that are required to be taken for global biosimilar acceptance.

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Section: Critical Challenges Of Biologics and Biosimilarsmentioning

confidence: 99%