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

  • Jorge Correale
    Correspondence
    Raúl Carrea Institute for Neurological Research, FLENI, Montañeses 2325, Buenos Aires 1428, Argentina.
    Affiliations
    Department of Neurology, Institute for Neurological Research Dr. Raúl Carrea, FLENI, Buenos Aires, Argentina
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Published:August 23, 2017DOI:https://doi.org/10.1016/j.jns.2017.08.3242

      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.

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