title: China's perspective on similar biotherapeutic products.
abstract: In order to ensure most Chinese patients, particularly in the population with relatively low incomes, have access to safe, low cost, effective and quality-assured medicines, a number of "stand-alone" biological products, which have good quality, safety and efficacy have been marketed in China. Many countries and regions' regulatory agencies are actively engaging in the development of bio-similar guidance and documents, which is being coordinated by WHO. As a major developing country of new drug development, China is now working hard to promote the process of new similar biotherapeutic products (SBPs) approval and also actively involved in developing and updating technical documents.
authors.affiliation: National Institutes for Food and Drug Control, 2 Tiantan Xili, Beijing, China. liangchenggang@nicpbp.org.cn
authors.forename: Chenggang
authors.initials: C
authors.lastname: Liang
authors.forename: Junzhi
authors.initials: J
authors.lastname: Wang
mesh_terms: D002681:China; D017277:Drug Approval; D004345:Drug Industry / Q000331:legislation & jurisprudence* / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards*; D011786:Quality Control
chemical_list: D004364:Pharmaceutical Preparations