Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products

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• 作者：Sven  ; Stegemann^a ;   ; ^{Sven.Stegemann@capsugel.com} ; Imre  ; Klebovich^b ; Istvá ; n  ; Antal^b ; Henning H.  ; Blume^c ; Ká ; lmá ; n  ; Magyar^d ; Gyö ; rgy  ; Né ; meth^e ; Tamá ; s L.  ; Paá ; l^f ; Willibald  ; Stumptner^g ; Gyö ; rgy  ; Thaler^e ; Armand  ; Van de Putte^a ; Vinod P.  ; Shah^h
• 关键词：Innovative drug products ; Generics and supergenerics ; Pharmaceutics and Biopharmaceutics ; Value of improved therapeutic entities ; Patient centric drug delivery ; Regulatory framework in FDA and EMA
• 刊名：European Journal of Pharmaceutical Sciences
• 出版年：2011
• 出版时间：20 November 2011
• 年：2011
• 卷：44
• 期：4
• 页码：447-454
• 全文大小：605 K

文摘

With a New Drug Application (NDA) innovative drug therapies are reaching the market in a specific dosage form for one or more clinically proven indications of which after expiration of the patent or the data exclusivity copies are launched using Abbreviated New Drug Applications (ANDA). Advanced therapies that emerged from launched molecules during their product life-cycle have gained considerable attention as clinical practice provides evidence for additional therapeutic values, patient centric delivery systems show improved therapeutic outcomes or emerging technologies offer efficiency gains in manufacturing or access to emerging markets. The USA and European regulatory framework has set reasonable regulations in place for these ¡°Supergenerics?or ¡°hybrid?applications. While these regulations are relatively recent the pharmaceutical industry is just starting to use this route for their product development and life-cycle management. From a clinical perspective the potential for advanced product development have been demonstrated. Yet, there is still a lag of common understanding between the different stakeholders regarding the development, application process and commercial incentive in developing enhanced therapeutic entities based on existing drug products for the market.