Highlights
- •Economic pressures are the major driving force for development of follow-on products.
- •High-quality medicines are essential to ensure optimal clinical impact for patients.
- •Small molecule follow-on products must demonstrate pharmaceutical equivalence.
- •To show therapeutic equivalence biosimilars required comparability clinical studies.
- •Pharmacovigilance programs for copies are not enforced in many LATAM countries.
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.
Keywords
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Article info
Publication history
Published online: August 23, 2017
Accepted:
August 22,
2017
Received in revised form:
August 21,
2017
Received:
May 16,
2017
Identification
Copyright
© 2017 Elsevier B.V. All rights reserved.
