Practical Issues Concerning the Approval and Use of Biosimilar Drugs for the Treatment of Multiple Sclerosis in Latin America

Abstract

The use of biosimilar drugs for multiple sclerosis (MS) has become widespread in Latin America, with the goal of reducing costs of treatments, promoting the sustainability of healthcare systems, and improving patient access to these therapies. There is currently a need to define and comply with requirements to guarantee the efficacy, safety, and quality of these drugs. Thus, the objective of the present study was to compile up-to-date information from each Latin American country assessed on (a) approval of biosimilar drugs by regulatory agencies; (b) use of biosimilar drugs, pharmacovigilance plans, risk management; and (c) update in the knowledge on different molecules. To do so, a group of experts from Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Ecuador, Mexico, Panama, Peru, Uruguay, and Venezuela met to discuss the current situation regarding good practices and risks associated with the use of biosimilar drugs in their respective countries. Regulation, risk management plans, and pharmacovigilance in the whole continent must guide the strategies on the commercialization and access of biosimilar drugs and copies of complex molecules. Current regulations must be implemented for the registration of biosimilar drug products and complex molecules. It is paramount to ensure that new products follow the best quality standards at all stages beyond being safe and efficient. Uncontrolled interchangeability between original biological and biosimilar should be avoided. Latin America requires the implementation and full use of strong pharmacovigilance programs. National and multinational clinical studies are required to demonstrate the similarity in safety, efficacy, and immunogenicity profiles of complex molecules, as well as biological and biosimilar products.Plain Language SummaryPlain language summary available for this article.

Central American and Caribbean Consensus for the Treatment of Multiple Sclerosis and Therapeutic Attitudes Facing the COVID-19 Pandemic

“…The lack of adequate assessments cannot guarantee safety and clinical efficacy similar to those of the reference product. Some of these molecules have been approved basically with no restrictions by national regulatory agencies, mostly with no evidence provided (15) Considering this fact, it is urgent for national regulatory agencies to establish sufficiently stringent guidelines to guarantee that drugs used to treat MS populations in the region are safe, effective, and of adequate industrial and pharmacological quality. These guidelines must specify whether the drug in question is a chemically synthesized molecule, a biologic drug or a complex nonbiologic drug, as there are recognized differences in manufacturing characteristics and quality assessments for each of these three major drug groups (16).…”

Biosimilar Drugs for Multiple Sclerosis: An Unmet International Need or a Regulatory Risk?

“…Only five Latin American countries (Brazil, Chile, Colombia, Panama and Venezuela) have health legalization limiting approval of biosimilars if clinical data are not available. An excellent recent paper (Neurology and Therapy, May 2019) [11] addresses practical issues concerning the approval and use of biosimilar drugs for the treatment of multiple sclerosis in Latin America. The study emphasizes the need for regulation, risk management, and pharmacovigilance of these products on the American continent.…”

“…Except for a few cases manufacturers have adhered to internationally established guidelines. The Latin American study group [11] emphasizes the need for implementation of current regulations to be applied to the registration of biosimilar drug products. The group proposes adequate national and multinational studies in the region to demonstrate similarity along with a strict post-marketing pharmacovigilance program.…”

Multiple Sclerosis: A Global Concern with Multiple Challenges in an Era of Advanced Therapeutic Complex Molecules and Biological Medicines

“…The economic impacts on individual and public health offered by the follow-on products have not been reflected in significant savings for the health systems [50]. Several international initiatives have developed, like the one promoted by the Latin American Committee for Treatment and Research in MS (LACTRIMS) [51], that encourage practitioners, MS study groups, and MS patient associations (most affiliated to the MSIF) from the region (20 countries) to coordinate with local health officials providing information and education on the licensing process, and even participating as independent advisors, striving for the proposed non-innovative follow-on medications to provide adequate clinical efficacy and safety data.…”