title: Improved therapeutic entities derived from known generics as an unexplored source of innovative drug products.
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.
authors.affiliation: Capsugel, Bornem, Belgium. Sven.Stegemann@capsugel.com
authors.forename: Sven
authors.initials: S
authors.lastname: Stegemann
authors.forename: Imre
authors.initials: I
authors.lastname: Klebovich
authors.forename: István
authors.initials: I
authors.lastname: Antal
authors.forename: Henning H
authors.initials: HH
authors.lastname: Blume
authors.forename: Kálmán
authors.initials: K
authors.lastname: Magyar
authors.forename: György
authors.initials: G
authors.lastname: Németh
authors.forename: Tamás L
authors.initials: TL
authors.lastname: Paál
authors.forename: Willibald
authors.initials: W
authors.lastname: Stumptner
authors.forename: György
authors.initials: G
authors.lastname: Thaler
authors.forename: Armand
authors.initials: A
authors.lastname: Van de Putte
authors.forename: Vinod P
authors.initials: VP
authors.lastname: Shah
mesh_terms: D004304:Dosage Forms; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence / Q000379:methods*; D004345:Drug Industry / Q000191:economics / Q000639:trends; D016568:Drugs, Generic / Q000737:chemistry / Q000191:economics; D005060:Europe; D006801:Humans; D009936:Organizational Innovation; D014481:United States
chemical_list: D004304:Dosage Forms; D016568:Drugs, Generic