We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- 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
- 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.
- Subjects
DRUG approval; GENERIC drugs; DRUG laws; DRUG standards; DRUG efficacy; REGULATORY approval
- Publication
Scientia Pharmaceutica, 2014, Vol 82, Issue 4, p847
- ISSN
0036-8709
- Publication type
Article
- DOI
10.3797/scipharm.1312-10