Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Global Development Strategy for Generic Medicinal Products with Regard to Bioequivalence Studies - Special Focus on the Biowaiver Approach in Canada, Australia and Brazil ***

Carolin Wedel (Abschlußjahr: 2012)

With the increasing globalisation of the drug industry many medicinal products are manufactured with the same formulation at the same manufacturing site for worldwide registration and distribution. If so for an innovator product, generic companies have one global reference product available and can consequently develop one global generic medicinal product. With regard to the necessary bioequivalence studies, harmonised requirements in different countries would be a great advantage. Ideally, only one global study program may be necessary for seeking marketing authorisations from regulatory authorities worldwide. But at present, there is still no uniform way of planning such a global bioequivalence study program for generic medicinal products. Most countries still insist on a bioequivalence study versus their national reference product. This is not always justified on the basis of scientific knowledge, but very often required for reimbursement and substitution purposes. In order to reduce costs and to avoid unnecessary exposure of subjects to drugs, regulatory authorities should become more willing to embrace the bridging approach, that is, bioequivalence studies performed versus innovator products from foreign countries. European regulatory authorities generally accept bioequivalence studies versus a reference product authorised in any country of the European Union (EU). The United States (US) Food and Drug Administration (FDA) requires studies versus the US innovator product. Canada and Australia accept bridging to relevant bioequivalence studies versus EU or US innovator products provided that certain criteria are fulfilled, whereas in Brazil the bridging approach is still not accepted.

Not only due to resource issues in the pharmaceutical industry, but also due to ethical reasons unnecessary bioequivalence studies should be waived. So-called biowaivers are usually accepted for specific dosage forms, for additional dose strengths, for scale-up and post-approval changes, or can be based on the biopharmaceutics classification system (BCS) or the bridging approach. For a global development strategy it is important to know the different biowaiver opportunities in different countries. There is still no consensus between regulatory authorities concerning biowaivers and bioequivalence study programs. Those regional differences make it very complex to plan a global development strategy for generic medicinal products with regard to bioequivalence studies.

The aim of this master thesis is to present an overview of the options to reduce the number of bioequivalence studies. The idea of a global development strategy for generic medicinal products is discussed. Special focus is laid on so-called biowaiver approaches in Canada, Australia and Brazil.

Pages: 55,
Annexes: 2, pages: 2