Browsing by Author "Duran Quiroz, Juan Carlos"
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- ItemPractical 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, AdrianaThe 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.
- ItemStatus of the neuromyelitis optica spectrum disorder in Latin America(ELSEVIER SCI LTD, 2021) Rivera, Victor M.; Hamuy, Fernando; Rivas, Veronica; Gracia, Fernando; Ignacio Rojas, Juan; Bichuetti, Denis Bernardi; Maria Villa, Andres; Marques, Vanessa Daccah; Soto, Arnoldo; Bertado, Brenda; Trevino Frenk, Irene; Galleguillos, Lorna; Quinones, Jairo; Ramirez, Deyanira A.; Caparo Zamalloa, Cesar; Ciampi Diaz Ethel Leslie; Lana Peixoto, Marco A.; Rodriguez, Emmanuel; Zarco, Luis; Sinay, Vladimiro; Armas, Elizabeth; Becker, Jefferson; Benzadon, Aron; Lopez, Ericka; Carnero Contentti, Edgar; Patricio Correa Diaz, Edgar; Diaz, Alejandro; Veronica Fleitas, Cynthia; Playas, Gil; Molina, Omaira; Rojas, Edgard; Sato, Douglas; Soto, Ibis; Vasquez Cespedes, Johana; Correale, Jorge; Barboza, Andres; Monterrey, Priscilla; Candelario, Awilda; Tavolini, Dario R.; Parajeles, Alexander; Pujol, Biany Santos; Diaz de la Fe, Amado; Alonso, Ricardo; Bolana, Carlos; Kagi Guzman, Marianne; Carra, Adriana; Gonzalez Gamarra, Oscar; Vera Raggio, Jose; Cesar Rodriguez, Luis; Eunice Ramirez, Nicia; Ordonez, Laura; Skromne, Eli; Lbeth Portillo, Ligia; Perez Canabal, Alfredo; Weiser, Roberto; Sirias, Vanessa; Fernandez Calderon, Ramiro; Arturo Cornejo, Ernesto; Hernandez, Marianella; Duran Quiroz, Juan Carlos; Alberto Garcia, Luis; Oviedo Cedeno, Carlos; Martinez, Jorge; Abad Herrera, PatricioBackground: Neuromyelitis optica spectrum disorders (NMOSD) is an increasing diagnostic and therapeutic challenge in Latin America (LATAM). Despite the heterogeneity of this population, ethnic and socioeconomic commonalities exist, and epidemiologic studies from the region have had a limited geographic and population outreach. Identification of some aspects from the entire region are lacking.