The regulatory framework for similar biotherapeutic products in Cuba

详细信息    查看全文

• 作者：Yanet Hechavarrí ; a Nú ; ñ ; ez  ; ;   ; ^{yanet@cecmed.sld.cu} ; Rodrigo Omar Pé ; rez Massipe ; Santa Deybis Orta Herná ; ndez ; Lá ; zara Martí ; nez Muñ ; oz ; Olga Lidia Jacobo Casanueva ; Violeta Pé ; rez Rodrí ; guez ; Rolando Bá ; rbaro Domí ; nguez Morales ; Rafael B. Pé ; rez Cristiá
• 关键词：Known biological product ; CECMED ; Polo Cientí ; fico del Oeste de La Habana ; Similar biotherapeutic product
• 刊名：Biologicals
• 出版年：2011
• 出版时间：September 2011
• 年：2011
• 卷：39
• 期：5
• 页码：317-320
• 全文大小：230 K

文摘

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.