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Abstract:Objective: The prevalence of multiple sclerosis (MS) in Latin America varies across different studies but an intermediate risk and increased frequency of the disease have been reported in recent years. The circumstances of Latin American countries are different from those of Europe and North America, both in terms of differential diagnoses and disease management. Methods: An online survey on MS was sent to 855 neurologists in nine Latin American countries. A panel of nine experts in MS analyzed the results. Results: Diagnostic and therapeutic recommendations were outlined with special emphasis on the specific needs and circumstances of Latin America. The experts proposed guidelines for MS diagnosis, treatment, and follow up, highlighting the importance of considering endemic infectious diseases in the differential diagnoses of MS, the identification of patients at high risk of developing MS in order to maximize therapeutic opportunities, early treatment initiation, and cost-effective control of treatment efficacy, as well as global assessment of disability. Conclusions: The experts recommended that healthcare systems allocate a longer consultation time for patients with MS, which must be conducted by neurologists trained in the management of the disease. All drugs currently approved must be available in all Latin American countries and must be covered by healthcare plans. The expert panel supported the creation of a permanent forum to discuss future clinical and therapeutic recommendations that may be useful in Latin American countries.

Biological drugs and nonbiological complex drugs with expired patents are followed by biosimilars and follow-on drugs that are supposedly similar and comparable with the reference product in terms of quality, safety and efficacy. Unlike simple molecules that can be copied and reproduced, biosimilars and follow-on complex drugs are heterogeneous and need specific regulations from health and pharmacovigilance agencies. A panel of 14 Latin American experts on multiple sclerosis from nine different countries met to discuss the recommendations regarding biosimilars and follow-on complex drugs for treating multiple sclerosis. Specific measures relating to manufacturing, therapeutic equivalence assessment and pharmacovigilance reports need to be implemented before commercialization. Physical, chemical, biological and immunogenic characterizations of the new product need to be available before clinical trials start. The new product must maintain the same immunogenicity as the original. Automatic substitution of biological and complex drugs poses unacceptable risks to the patient.

it is important to investigate the efficacy and safety profile of fingolimod using ethnically relevant data. Here, we review key data from Hispanic patients enrolled in the fingolimod clinical trial program, summarize recent findings from the FIRST LATAM study, and appraise fingolimod data from real-world patient populations.Funding: Novartis Pharma AG, Basel, Switzerland.

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