生物相似性药品之审查考量.pdfVIP

生物相似性藥品之審查考量 醫藥品查驗中心 (Center for Drug Evaluation) Division of New Drugs Senior Team Leader 陳紀勳醫師 2017-Oct-12 本次演講內容僅代表查驗中心之觀點， 凡涉及政策方向及法規解釋與適用， 應依衛生主管機關之指示為準。 2 Biosimilar Drugs 定義 生物相似性藥品指 以生物技術衍生之生物藥品， 於品質、安全及療效 上， 與獲得我國核准之原開發廠生物藥品(參 考品， reference drug)相似 範圍 :重組胜肽、重組蛋白質 不包括疫苗，致敏原，血液或血漿衍生製劑及其重 組替代物，以及如基因或細胞治療產品等。 3 仿製藥 小分子藥 →學名藥 (generic drug) Regulatory requirement: Quality + BE 大分子蛋白質藥 →生物相似性藥品(biosimilar) Regulatory requirement: more complex → need detail Guidelines (comparative exercises) Protein Drugs vs. Chemical Drugs Protein Drugs Chemical Drugs Large size Small molecule M.W. 10,000 Daltons mostly M.W. 1,000 Daltons Complex Structure Simple straight forward structure 1) three dimension (1 ，2 ，3 ，4 級結構) 2) acido-basic variants 3) post-translational modification (glycosylation profile) Produced by biosynthetic processes, cannot Identical structure reproducible be easily reproduced Administered by injection Several routes immunologic response Protein Drugs vs. Chemical Drugs Mellstedt H. EJC Supplements 2013;11:1-11. Therefore, while developing new drugs imitating marketed products, protein drugs are …. More difficult to characterize the detail whole structure → nearly not possible to demonstrate EQUIVALENCE Subtly different from reference drugs. Not applicable for traditional generic bioequivalence approach. Different Terms 