Update on Biosimilars — Complexity of Biologics and Clinical Concerns: Importance of Proper Evaluation
VWY Lee
Hong Kong J Radiol 2012;15(Suppl):S72-4
Biopharmaceuticals or biologics were first introduced at the beginning of the 1980s and are now well established in the treatment of a wide variety of diseases. Biosimilars are biopharmaceuticals that are similar, but not identical, to a marketed innovator product, typically one with an expired patent. Although the market share of biosimilars remains in its infancy in many places, this is expected to change markedly over the coming decades. In the clinical setting, it is vital that prescribers understand that biosimilars cannot be considered interchangeable generic versions of the original biologic. The exceptionally complex manufacturing processes required for biologics makes it highly unlikely that another manufacturer will generate a product identical to the original biopharmaceutical. Any slight variation in the conditions of manufacture can result in a deviation from the reference compound structure with consequent changes in clinical performance. The potential dangers of such a situation have already been clearly illustrated by the emergence of antibody-mediated pure red cell aplasia in patients treated with recombinant human erythropoietin. Expert and regulatory authorities in Europe and the USA have recognised that the established process for evaluation and market approval of generic drugs cannot be applied to biosimilars; the current recommended procedures for regulatory approval and ongoing safety monitoring of biosimilars will be reviewed.
中文摘要
生物仿製藥的最新資料：生物製劑的複雜性和臨床關注， 其正確評價的重要性
李詠恩
生物製藥或生物製劑在八十年代初開始，時至今日已廣泛用作醫治多種類型的疾病。生物仿製藥是 與市場上已過專利期的生物製劑有類似（但非一模一樣）的藥物。雖然從多方面的角度看，生物仿 製藥的發展仍屬初步階段，但在未來的日子，情況預計會有巨大的轉變。臨床上，處方者必須明白 生物仿製藥不能被視為等同原本生物製劑的通用版本。這點相當重要，因為生物製劑極其複雜的製 造過程，令其他製造商不可能產生一種相同的生物藥品。製造條件中任何輕微的變化都可以引致與 參考化合物結構有所偏差，而導致臨床表現有不同。類似的情況可以從重組人類紅血球生成素治療 引發抗體造成的純紅血球再生不良的病例中顯示生物仿製藥的潛在危險。歐洲及美國的專家和監管 機構已經意識到，用來評估和審批生物製劑的既定過程不能應用在生物仿製藥上。本文回顧監管部 門對於生物仿製藥目前使用的審查程序和安全監測。