Abstract
Insulin analogues are increasingly considered as an alternative to human insulin in the therapy of diabetes mellitus. Insulin analogues (IAs) are chemically different from human insulin and may have different pharmacokinetic or pharmacodynamic properties. The significance of the modifications of the insulin molecule for the safety profile of IAs must be considered. This review describes the regulatory procedure and the expectations for the scientific content of European marketing authorization applications for innovative IAs submitted to the European Medicines Agency. Particular consideration is given to a potential cancer hazard. Specific regulatory guidance on how to address a possible carcinogenic or tumor promoting effect of innovative IAs in non-clinical studies is available. After marketing authorization, the factual access of patients to the new product will be determined to great extent by health technology assessment bodies, reimbursement decisions and the price. Whereas the marketing authorization is a European decision, pricing and reimbursement are national or regional responsibilities. The assessment of benefit and risk by the European Medicines Agency is expected to influence future decisions on price and reimbursement on a national or regional level. Collaborations between regulatory agencies and health technology assessment bodies have been initiated on European and national level to facilitate the use of the European Medicines Agency's benefit risk assessment as basis on which to build the subsequent health technology assessment. The option for combined or joint scientific advice procedures with regulators and health technology assessment bodies on European level or on a national level in several European Member States may help applicants to optimize their development program and dossier preparation in regard of both European marketing authorization application and reimbursement decisions.
Highlights
Subcutaneous insulin remains the backbone for the treatment of diabetes mellitus in Europe when oral antidiabetic medicinal products are not effective or no longer sufficient
At variance with the human insulin formulation for inhalation, several Insulin analogues (IAs) have been successfully introduced on the European market
In addition to the basic demonstration of efficacy and safety, particular consideration is given to a potential cancer hazard
Summary
Subcutaneous insulin remains the backbone for the treatment of diabetes mellitus in Europe when oral antidiabetic medicinal products are not effective or no longer sufficient. The interface between regulatory and health technology assessment The demonstration of efficacy, safety and pharmaceutical quality may be sufficient to attain the European marketing authorization This may, not be equal to the factual access of patients to the new product as pricing and reimbursement decisions depend on national or regional health systems [20]. To foster the early alignment of different stakeholders, joint scientific advice procedures by regulators and health technology assessment bodies are developed on European or national level [22,23,24] This is a promising way to avoid European marketing authorization decisions that have little or no consequence for patients who do not have access to the licensed product for economic reasons. Whereas this alignment process may be relevant for all innovative medicinal products, it may be relevant in the ongoing discussion on the price and reimbursement for IAs in important European markets [25]
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