title: Review on the worldwide regulatory framework for biosimilars focusing on the Mexican case as an emerging market in Latin America.
abstract: The global biopharmaceutical market is worth over $100 billion USD. Nearly 90% of these products will lose their patent in the next ten years, leading to the commercialization of their subsequent versions, known as 'biosimilars'. Biosimilars are much more complex molecules than chemically synthesized generics in terms of size, structure, stability, microheterogeneity, manufacture, etc. Therefore, a specific regulatory framework is needed in order to demonstrate their comparability with innovative products, as well as their quality, safety and efficacy. The EU published the first regulatory pathway in 2005 and has approved 14 biosimilars. Mexico has recently developed a clear regulatory pathway for these products. Their legal basis was established in Article 222 Bis of General Law of Health in 2009, clear specifications in the Regulation for Health Goods in 2011, and further requirements in the Mexican Official Norm NOM-EM-001-SSA1-2012. The aim of this review is to summarize the regulatory pathways for biosimilars in the world with a special focus on Mexican experience, so as contribute to the development of regulations in other countries.
authors.affiliation: INBIOXICA, S.A. de C.V., Cañaverales 60 #38, Colonia Rinconada Coapa, Tlalpan, CP: 14330 Mexico City, Mexico. Electronic address: ricardoibarra27@gmail.com.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Ibarra-Cabrera
authors.forename: Sandra Carolina
authors.initials: SC
authors.lastname: Mena-Pérez
authors.forename: Augusto
authors.initials: A
authors.lastname: Bondani-Guasti
authors.forename: Roeb
authors.initials: R
authors.lastname: García-Arrazola
mesh_terms: D059451:Biosimilar Pharmaceuticals; D007880:Legislation, Drug; D008800:Mexico; D014944:World Health Organization
chemical_list: D059451:Biosimilar Pharmaceuticals
keywords: BPCI Act; Biologics Price Competition and Innovation Act; Biopharmaceuticals; Biosimilars; COFEPRIS; Comisión Federal para la Protección contra Riesgos Sanitarios; Comparability; Evaluation guidelines; Mexican law; PAHO; Pan-American Health Organization; Regulatory framework