| 摘要: | 自2006年歐盟核准第一個生物相似性藥品以來，有別於生物新藥的上市許可路徑與規範逐漸明朗。目前，肇因於生物藥品價格高昂為醫療保險體系帶來沉重負擔與多種銷售良好的生物藥品專利即將屆滿等兩大因素，生物相似性藥品市場於近幾年更加蓬勃發展，預計在2020年達到300億美元。但台灣佔全球市場份額小，促使台灣生物相似性藥品開發商於制定上市許可策略時傾向以全球主要市場作為標的，因此，本論文就以生物藥品全球市場份額第一的美國、最早具有生物相似性藥品規範且為全球市場份額第二的歐盟、生物藥品市場發展迅速的中國最為全球上市許可規範的代表，並以上述三個地區與台灣規範進行討論與整合。
在論文中依據國際醫藥法規協合會推出的通用技術文件格式，將上市行可所需規範分為技術性與行政性，前者於第三章至第六章說明，主要以四個地區的生物相似性藥品技術性規範做為討論範圍，後者則於第七與第八章說明，主要討論藥物優良品質管理規範與上市許可申請程序等行政議題。在比較與整合四個地區的規範後，於第九章進行生物相似性藥品上市許可策略總結與討論台灣規範的差異為何，以利藥品開發商與政府參考與利用。
Since the first biosimilar product was approved by the EU in 2006, the marketing administrative approval pathway and regulations that are distinct from the biological product were emerged. Right now, there are two reasons to gradually flourish the biosimilar market in recent years, one is the heavy burden of health insurance system from the high price of biological product the other one is the coming patent expiration of the top selling biological product. By 2020 it is predicted to generate $30 billion in revenue of the global market for biosimilar product, but Taiwan will have a little market share of the global market. In this situation, drug developers in Taiwan tend to scheme a marketing administrative approval strategy that can focus on some specific market shares of the global market. Therefore, in this paper there are three countries chosen to represent the global market, the USA which has the largest market share of the global market for biological product, the EU which has the farthest biosimilar regulations and the second market share of the global market for biological product, China which has the most rapidly development of the biological product market, the biosimilar regulations of the above mentioned three countries are compared to that of Taiwan and are discussed.
According to the common technical document format of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use, dividing regulations of biosimilar marketing administrative approval into technical and administrative parts in this paper. In chapter 3 to 6 the technical regulations of biosimilar of the 4 countries, and in chapter 7 to 8 administrative regulations, such as guidance of good practice, marketing administrative approval procedure, leaflet, labeling, etc are discussed. After comparing and integrating technical and administrative parts of the 4 countries, the summaries of the biosimilar marketing administrative approval strategy, and the differences between the other countries and Taiwan are mentioned in chapter 9, and offering some ideas to the drug developers and the government are also mentioned in the same chapter. |
