Follow-on products for treatment of multiple sclerosis in Latin America: An update.

Abstract:

:Both proprietary and non-proprietary medicines are expected to undergo rigorous pre-approval testing and both should meet stringent health authority regulatory requirements related to quality to obtain approval. Non-proprietary (also known as copy or generic) medicines, which base their authorization and use on the proprietary documentation and label, are often viewed as a means to help lower cost and thus increase patient access. If these medicines fail to meet quality standards, such as good manufacturing practice and bioequivalence (in humans), they are then defined as substandard copies and can pose serious risks to patients in terms of safety and efficacy. Availability of this type of compounds is more prevalent in regions where health authorities do not enforce registration regulations as stringent as those of the Food and Drug Administration, European Medicines Agency, or World Health Organization, including preestablished quality standard requirements. This article focuses on non-proprietary medicines for multiple sclerosis, that are not identical to proprietary versions and could thus fail to meet efficacy or have different impact on the safety of patients with multiple sclerosis.

journal_name

J Neurol Sci

authors

Correale J

doi

10.1016/j.jns.2017.08.3242

subject

Has Abstract

pub_date

2017-10-15 00:00:00

pages

153-159

eissn

0022-510X

issn

1878-5883

pii

S0022-510X(17)33738-3

journal_volume

381

pub_type

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