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Title: Licensing of generic medicines : are there any challenges left? A pharmaceutical regulatory perspective
Authors: Borg, John Joseph
Tomasi, Paolo
Pani, Luca
Aislaitner, George
Pirozynski, Michal
Leufkens, Hubert
Melchiorri, Daniela
Keywords: Drugs
Generic drugs
Drugs -- Therapeutic equivalency
Brand name products
Parkinson's disease
Issue Date: 2014
Publisher: Osterreichische Apotheker-Verlagsgesellschaft m.b.H.
Citation: Borg, J. J., Tomasi, P., Pani, L., Aislaitner, G., Pirozynski, M., Leufkens, H., & Melchiorri, D. (2014). Licensing of generic medicines: Are there any challenges left? A pharmaceutical regulatory perspective. Scientia Pharmaceutica, 82(4), 847-856.
Abstract: When an innovative product (innovator) is not covered anymore by intellectual property rights, cheaper equivalent medicinal products (generic products) may be marketed and used in clinical practice. The regulation of generic products is well-established, and is primarily based on standard rules for quality, therapeutic equivalence requirements (the latter in most instances proven through a bioequivalence study), and safety data for the innovator. The extensive experience from bringing generic products to the market over the last decades allows the conclusion that they are well-accepted and provide a useful alternative option for cost-effective pharmacotherapy. While supporting this conclusion, there are a number of issues to be considered during the assessment of a generic product application. Six scenarios are described in total, from an efficacy and a safety perspective, where potential concerns with the current regulatory standards could arise in the approval of generic products. We also propose solutions to these scenarios in order to foster debate on these issues.
Appears in Collections:Scholarly Works - ERCMedGen

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