| アブストラクト | INTRODUCTION: Biologics have improved the treatment of rheumatic diseases, resulting in better outcomes. However, their high cost limits access for many patients in both North America and Latin America. Following patent expiration for biologicals, the availability of biosimilars, which typically are less expensive due to lower development costs, provides additional treatment options for patients with rheumatic diseases. The availability of biosimilars in North American and Latin American countries is evolving, with differing regulations and clinical indications. OBJECTIVE: The objective of the study was to present the consensus statement on biosimilars in rheumatology developed by Pan American League of Associations for Rheumatology (PANLAR). METHODS: Using a modified Delphi process approach, the following topics were addressed: regulation, efficacy and safety, extrapolation of indications, interchangeability, automatic substitution, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. Consensus was achieved when there was agreement among 80% or more of the panel members. Three Delphi rounds were conducted to reach consensus. Questionnaires were sent electronically to panel members and comments about each question were solicited. RESULTS: Eight recommendations were formulated regarding regulation, pharmacovigilance, risk management, naming, traceability, registries, economic aspects, and biomimics. CONCLUSION: The recommendations highlighted that, after receiving regulatory approval, pharmacovigilance is a fundamental strategy to ensure safety of all medications. Registries should be employed to monitor use of biosimilars and to identify potential adverse effects. The price of biosimilars should be significantly lower than that of reference products to enhance patient access. Biomimics are not biosimilars and, if they are to be marketed, they must first be evaluated and approved according to established regulatory pathways for novel biopharmaceuticals. KEY POINTS: * Biologics have improved the treatment of rheumatic diseases. * Their high cost limits access for many patients in both North America and Latin America. * Biosimilars typically are less expensive, providing additional treatment options for patients with rheumatic diseases. * PANLAR presents its consensus on biosimilars in rheumatology. |
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| 投稿者 | Kowalski, S C; Benavides, J A; Roa, P A B; Galarza-Maldonado, C; Caballero-Uribe, C V; Soriano, E R; Pineda, C; Azevedo, V F; Avila-Pedretti, G; Babini, A M; Cachafeiro-Vilar, A; Cifuentes-Alvarado, M; Cohen, S B; Diaz, P E; Soto, L Diaz; Encalada, C; Garro, B; Sariego, I A G; Guibert-Toledano, M; Rodriguez, V J K; Lopez, M E L; Ortega, A P; Russell, A S; Santos-Moreno, P; Teran, I S; Vargas, A; Vasquez, G; Xavier, R M; Firedman, D X Xibille; Mysler, E; Kay, J |
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| 組織名 | Universidade Federal do Parana, R. Gen. Carneiro, 181 - Alto da Gloria, Curitiba,;PR, 80060-900, Brazil. sckowalskii@gmail.com.;Cencis, Av. Cra 45 # 114-78 Edificio Espectrum, oficina 101, Bogota, Colombia.;PANLAR (Pan American League of Associations for Rheumatology), 2200 Lake;Boulevard NE, Atlanta, GA, 30319, USA.;UNERA-Unidad de Enfermedades Reumaticas y Autoinmunes, Corporacion Medica Monte;Sinai, 010107, Cuenca, Ecuador.;Hospital Universidad del Norte-Unidad de Reumatologia, Calle 30 Via Al;Aeropuerto, Soledad-Atlantico, Colombia.;Sociedad Paraguaya de Reumatologia, Pitiantuta 613 esq. Juan de Salazar,;Asuncion, Paraguay.;Sociedad Argentina de Reumatologia, Callao 384 Piso 2 Dto 6, CABA, C1022AAQ,;Buenos Aires, Argentina.;Sociedad Panamena de Reumatologia, Boulevard Pacifica y Via Punta Darien, Panama;City, Panama.;Asociacion Guatemalteca de reumatologia, 10a. Calle 6-40. Zona 9 Clinica 1. 2do;Nivel Edificio Salucentro, Guatemala City, Guatemala.;American College of Rheumatology, 2200 Lake Boulevard NE, Atlanta, GA, 303192200,;USA.;Sociedad Boliviana de Reumatologia, Instituto Boliviano de Reumatologia, Av.;Irala, Santa Cruz de la Sierra, Bolivia.;Asociacion Costarricense de Reumatologia, Reumatologia, Hospital Mexico, Caja;Costarricense del Seguro Social, San Jose, Costa Rica.;Sociedad Ecuatoriana de Reumatologia, Edificio Torre Medica #4 Piso 1, Coronel;2207 y canar (994,96 km), Guayaquil, Ecuador.;Sociedad Peruana de Reumatologia, Av. Jose Pardo 138 oficina 1206 Miraflores,;Lima, Peru.;Sociedad Chilena de reumatologia, Av. Nueva Providencia, 2214, Providencia,;Region Metropolitana, Chile.;Sociedad Cubana de Reumatologia, Calzada de 10 de Octubre # 122, esquina Agua;dulce Cerro, Havana, Cuba.;Sociedad Dominicana de Reumatologia, Primer Nivel Local 47 A. Diamond Mall, Santo;Domingo, Dominican Republic.;Asociacion de Reumatologia Nicaraguense, Bello Horizonte rotonda 4 (1/2) cuadras;al sur. J II 9, Managua, Nicaragua.;Canadian Rheumatology Association, 9-6975 Meadowvale Town Centre Circle Suite 108;Mississauga, Toronto, Ontario, L5N 2V7, Canada.;Asociacion Colombiana de Reumatologia, Calle 94 # 15-32 Oficina 603, Bogota,;Colombia.;Sociedad Venezolana de Reumatologia, Apartado 5495, Caracas, 1010, Venezuela.;Sociedad Uruguaya de Reumatologia, Av.Italia s/n esq. Las Heras 1er. Piso Sector,;Montevideo, Uruguay.;Sociedade Brasileira de Reumatologia, Av. Brigadeiro Luis Antonio, 2466 - Jardim;Paulista, Sao Paulo, SP, 01402-000, Brazil.;Colegio Mexicano de Reumatologia, Paseo del Rio No. 157 Col. Barrio Oxtopulco;Universidad, Delegacion Coyoacan, Cd., CP 04318, Mexico City, Mexico. |
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