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

Sven Stegemann, Imre Klebovich, István Antal, Henning H. Blume, Kálmán Magyar, György Németh, Tamás L. Paál, Willibald Stumptner, György Thaler, Armand Van De Putte, Vinod P. Shah

Research output: Contribution to journalReview article

14 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)447-454
Number of pages8
JournalEuropean Journal of Pharmaceutical Sciences
Volume44
Issue number4
DOIs
Publication statusPublished - Nov 20 2011

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Keywords

  • Generics and supergenerics
  • Innovative drug products
  • Patient centric drug delivery
  • Pharmaceutics and Biopharmaceutics
  • Regulatory framework in FDA and EMA
  • Value of improved therapeutic entities

ASJC Scopus subject areas

  • Pharmaceutical Science

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