作者: Ricardo Teixo , Camila dos Reis , Biophysics Unit-IBILI , Rui Santos Cruz , Fernando Mendes
DOI:
关键词: Comparability 、 Interchangeability 、 Quality (business) 、 Risk analysis (engineering) 、 Biosimilar 、 Review article 、 Pharmacology 、 Marketing authorization 、 Alternative medicine 、 Targeted therapy 、 Medicine
摘要: By definition, biosimilars are similar to a biological reference that has already received marketing authorization for biologic drugs. The purpose of is reducing costs, thus increasing access this treatment, however, the concerns health professionals and users refer fact reduce costs will not neglecting quality, effectiveness especially security. aim study then assess degree similarity between biosimilar its biopharmaceuticals, trying understand production process, requirements necessary approval, impact on safety, efficacy costs. METHODS: For systematic review without meta-analysis, we researched articles b-on, Pubmed Medscape 2005-2014, selected 23 contributed verification objectives study. RESULTS: Several studies indicate overall showed no significant differences except those inherent being first susceptible comparability tests demonstrating in terms clinical safety. CONCLUSION: Biosimilars be increasingly present future as promising therapeutic arsenal targeted therapy, issues related immunogenicity, interchangeability, automatic substitution extrapolation indications should continue studied debated.