Browsing by Author "Rodriguez, Virginia"

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    Practical Issues Concerning the Approval and Use of Biosimilar Drugs for the Treatment of Multiple Sclerosis in Latin America
    (2019) Steinberg, Judith; Dadalti Fragoso, Yara; Duran Quiroz, Juan Carlos; García,Juan Raul; Guerra, Caroline; Rodriguez, Virginia; Cárcamo Rodríguez, Claudia Andrea; Ciampi Diaz, Ethel Leslie; Correa-Diaz, Edgar; Macías, Miguel; Novarro, Nelson; Vizcarra, Darwin; Oehninger Gatti, Carlos; Orozco, Geraldine; Carrá, Adriana
    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.
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    Practical issues concerning the use of optical coherence tomography in multiple sclerosis in Latin America: Discussion from 19 centres on behalf of the Foro Latam EM study group
    (2025) Ciampi Diaz, Ethel Leslie; Garcia, Lorena; Carcamo Oyarzo, Claudio Marcelo; Soler León, Bernardita María; Becker, Jefferson; Carra, Adriana; Correa-Diaz, Edgar; Cortes, Fernando; Garcia Bonitto, Juan; Guerra, Carolina; Macias, Miguel Angel; Martinez, Alejandra; Novarro, Nelson; Rivera-Sarabia, Linda; Rocha, Valeria; Rodriguez, Virginia; Sato, Douglas; Steinberg, Judith; Trevino Frenk, Irene; Vasquez, Guido; Pena, Luis
    The 2024 McDonald Criteria now include the optic nerve as the fifth topography for dissemination in space. Optical coherence tomography (OCT) is a valuable biomarker for the diagnosis, prognosis and monitoring of multiple sclerosis (MS). A panel of MS neurologists from 19 centres across 9 Latin American (LATAM) countries discussed OCT use, access, standardized protocols and research potential. They found inequities in OCT access between private (80%) and public healthcare (44%). Only 9 centres had standardized protocols, 50% of which followed the OSCAR-IB consensus criteria for retinal OCT quality assessment and 53% had a neuro-ophthalmologist. The panel concluded that OCT should be available in all MS centres and that standardized acquisition and reporting, as well as improved knowledge of OCT use, in clinical practice are necessary. OCT has significant research potential in LATAM that requires further development and implementation.
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    Practical issues concerning the use of optical coherence tomography in multiple sclerosis in Latin America: Discussion from 19 centres on behalf of the Foro Latam EM study group
    (Elsevier, 2025) Ciampi Diaz, Ethel Leslie; Garcia, Lorena; Carcamo Oyarzo, Claudio Marcelo; Soler León, Bernardita María; Becker, Jefferson; Carra, Adriana; Correa-Diaz, Edgar; Cortes, Fernando; Garcia Bonitto, Juan; Guerra, Carolina; Macias, Miguel Angel; Martinez, Alejandra; Novarro, Nelson; Rivera-Sarabia, Linda; Rocha, Valeria; Rodriguez, Virginia; Sato, Douglas; Steinberg, Judith; Trevino Frenk, Irene; Vasquez, Guido; Pena, Luis
    The 2024 McDonald Criteria now include the optic nerve as the fifth topography for dissemination in space. Optical coherence tomography (OCT) is a valuable biomarker for the diagnosis, prognosis and monitoring of multiple sclerosis (MS). A panel of MS neurologists from 19 centres across 9 Latin American (LATAM) countries discussed OCT use, access, standardized protocols and research potential. They found inequities in OCT access between private (80%) and public healthcare (44%). Only 9 centres had standardized protocols, 50% of which followed the OSCAR-IB consensus criteria for retinal OCT quality assessment and 53% had a neuro-ophthalmologist. The panel concluded that OCT should be available in all MS centres and that standardized acquisition and reporting, as well as improved knowledge of OCT use, in clinical practice are necessary. OCT has significant research potential in LATAM that requires further development and implementation.