Xibille Daniel, Carrillo Sandra, Huerta-Sil Gabriela, Hernández Ramiro, Limón Leonardo, Olvera-Soto Guadalupe, Jara-Quezada Luis Javier, Esquivel Abdieel, Pérez-Rodríguez Marcela
Jefatura de Investigación y Capacitación, Servicios de Salud del Estado de Morelos, México; Colegio Mexicano de Reumatología, Ciudad de México, México.
Colegio Mexicano de Reumatología, Ciudad de México, México; Departamento de Reumatología, Hospital Primero de Octubre, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (ISSSTE), Ciudad de México, México.
Reumatol Clin (Engl Ed). 2018 May-Jun;14(3):127-136. doi: 10.1016/j.reuma.2017.07.002. Epub 2017 Aug 12.
The present document is a position statement of the Mexican College of Rheumatology on the use of biosimilars in rheumatic diseases. This position considers that biosimilars should be considered as interchangeable, that automatic substitution without previous notice in stable patients during follow-up is not ethical, that the approval of a biosimilar should only be given after exhaustive review of preclinical and clinical data marked by Mexican regulations, that it should be clearly stated in the nomenclature of biologic drugs which is the innovator and which is the biosimilar, that it is not correct to choose a biosimilar as treatment based only on economic reasons or extrapolate indications based only on the approval of the innovator and in the absence of safety and efficacy data for the biosimilar.
本文件是墨西哥风湿病学会关于生物类似药在风湿性疾病中应用的立场声明。该立场认为，生物类似药应被视为可互换的，在随访期间对病情稳定的患者不提前通知就进行自动换药是不符合伦理的，生物类似药的批准应仅在按照墨西哥法规对临床前和临床数据进行详尽审查之后给予，生物制品药物的命名中应明确指出哪种是创新药，哪种是生物类似药，仅基于经济原因选择生物类似药作为治疗手段或仅根据创新药的批准情况而在缺乏生物类似药安全性和有效性数据的情况下外推适应证都是不正确的。
