title: The regulatory framework for similar biotherapeutic products in Cuba.
abstract: Biopharmaceuticals make up a significant proportion of medicinal products used for the treatment of diseases such as cancer, arthritis, cardiac dysfunctions and AIDS. Access to therapies based on the use of these products has been limited as a result of the high marketing costs. Cuba has a biopharmaceutical industry with great potential for innovation, capable of developing new products and to produce others, like the biosimilars destined to fulfill the needs of its National Health System. The Center for State Control on the Quality of Drugs (CECMED) the Cuban NRA, is facing the challenge of regulating the approval of biosimilar products manufactured locally. Consequently, CECMED has issued a position paper establishing the basic principles for regulation of these products and a specific guideline on this was elaborated.
authors.affiliation: Centro para el Control Estatal de la Calidad de los Medicamentos, Calle 200 No.1706 e/17 y 19, Reparto Siboney, Havana City, Cuba. yanet@cecmed.sld.cu
authors.forename: Yanet
authors.initials: Y
authors.lastname: Hechavarría Núñez
authors.forename: Rodrigo Omar
authors.initials: RO
authors.lastname: Pérez Massipe
authors.forename: Santa Deybis
authors.initials: SD
authors.lastname: Orta Hernández
authors.forename: Lázara Martínez
authors.initials: LM
authors.lastname: Muñoz
authors.forename: Olga Lidia
authors.initials: OL
authors.lastname: Jacobo Casanueva
authors.forename: Violeta
authors.initials: V
authors.lastname: Pérez Rodríguez
authors.forename: Rolando Bárbaro
authors.initials: RB
authors.lastname: Domínguez Morales
authors.forename: Rafael B
authors.initials: RB
authors.lastname: Pérez Cristiá
mesh_terms: D003462:Cuba; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000458:organization & administration / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug; D009313:National Health Programs / Q000331:legislation & jurisprudence* / Q000458:organization & administration / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control
chemical_list: D004364:Pharmaceutical Preparations