Tyrosine kinase inhibitors becoming generic drugs – risks and chances from a regulatory perspective
Journal Title: Generics and Biosimilars Initiative Journal - Year 2014, Vol 3, Issue 2
Abstract
Aim: To provide a systematic overview on: i) safety profiles; ii) pharmacokinetic parameters; and iii) regulatory framework of anti-cancer tyrosine kinase inhibitors (TKI). Methodology: Recherché of pharmakokinetic (PK)-parameter: i) Germany’s federal drug database (public domain part) was accessed in November 2013. Section 5.2 (PK) of Summary of Product Characteristics systematically was searched for available PK-parameters, and ii) A search in PubMed/Medline was performed also in November 2013 using the international non-proprietary name of the respective medicinal product combined with the term ‘early phase’ or ‘dose escalation’. PubMed recherché was restricted by searching only in clinical trials. Safety profile assessment: On 11 November 2013, Summary of Product Characteristics of currently marketed medicinal products was accessed. Side effects were categorized as mentioned in the table’s legend by frequency for each preferred term of the systems organ class system. Source: Summary of Product Characteristics published on the Heads of Medicines Agencies homepage: http://mri.medagencies.org/Human Results: PK-parameters and safety profiles are presented in the respective tables. Throughout the text, clinical meaning, orphan drug status and current discussion on narrow therapeutic index (NTID)-status by European committees and working parties is discussed. Conclusion: Tyrosine kinase inhibitors are a valuable addition of the therapeutic armamentarium. Especially in certain haematologic diseases, i.e. chronic myeloid leukaemia (CML)-therapy, TKI have revolutionized pharmacotherapy with survival rates not significantly different from healthy matched population. However, as their safety profile differs substantially from conventional cytostatic drugs, new side effects impact on patient’s quality of life. About ten years after first substances were authorized, patent protection will end within the next years. Thus, product specific guidance is needed to accurately perform bioequivalence studies and file marketing authorization applications for registration of TKI-generics.
Authors and Affiliations
Niels Eckstein, Lea Röper, Bodo Haas, Henrike Potthast, Ulrike Hermes, Christoph Unkrig, Frauke Naumann-Winter, Harald Enzmann
The potential of generics policies: more room for exploitation–PPRI Conference Report
Introduction: This Conference Report aims to provide an overview of key results, messages and conclusions of the Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference with regard to generics. Methods: Th...
Pharmacokinetics of antimicrobials in obese children
Introduction: Childhood obesity is common and results in substantial morbidity. The most commonly prescribed drugs in obese children are antibiotics. However, physiological changes associated with childhood obesity can a...
Current status of biopharmaceuticals in Iran’s pharmaceutical market
The clinical importance of biopharmaceuticals for the management of life threatening diseases is increasing but costs have become a major obstacle to the administration of these medicines, especially in resource limited...
Biosimilar development and regulation in Japan
In Japan, biosimilars guidelines following the principles of the EU framework were established by Japan’s Ministry of Health, Labor and Welfare in March 2009. The guidelines cover the manufacturing process, characterizat...
Equal protection under the law: Children and the Best Pharmaceuticals for Children Act
Four changes to the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act will markedly improve these programmes: expanded attention paid to neonatal studies, support for the off -patent programme,...