Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Balancing Regulatory and Economic Aspects in the Development of Generics – a Business Case ***

Dr. Bernhard Wenkers (Abschlußjahr: 2005)

Language: English

Generic medicinal products enjoy an increasing importance vis-à-vis the innovative medicinal products. Due to cost-savings, they contribute significantly to the economic provision of medicinal products for the patients. Therefore, the generic competition is also a political issue.

Generic medicinal products have to be comparable with the respective innovator (originator) products concerning quality, safety and efficacy. This comparability has to be demonstrated to the regulatory authorities by means of appropriate chemical-pharmaceutical, and, if applicable, toxico-pharmacological and clinical bridging documentation submitted with the application for marketing authorisation. Special requirements on substantiating this comparability are applied to generic herbal medicinal products and biopharmaceuticals, because they are not only characterised by their complex therapeutically active principals and pharmaceutical forms, but also by their manufacturing processes.
At present, these requirements are being discussed between the regulatory authorities and the pharmaceutical industry regarding impact on cost when transferred into action. On dealing with these challenges also an economically acceptable time frame should be observed, in order to guarantee future financing of the health-care system.

A pre-condition for each pharmaceutical company to cope with these challenges is the compliance with regulatory demands on standard pharmaceutical products, e. g. tablets, capsules, liquids, creams and ointments. Therefore, a business case based on the example of the fictitious generic company GenericsPharming GmbH located in Pharmaburg in Germany has been compiled to reflect these basic demands.

The generic market is characterised by strong competition and high pressures of costs and prices. Therefore, generic companies face the necessity to introduce continuously new products into the market as close as possible to the respective active substance patent expiry dates, in order to achieve maximum prices, sales and profits.

Within tight timelines a product has to be developed essentially similar to the originators, registered and launched, while observing numerous patent and registration issues. Thereby, the management tools of the situation appraisal, decision analysis and potential problem analysis have to be applied to generate a differentiated overview of the situation, to derive substantiated decisions for the further activities and to assess the potential problems and risks.

The thesis presents these management tools within the scope of the business case. The established generic company GenericsPharming GmbH located in Pharmaburg in Germany is faced with an economically serious situation and has to develop and register a new generic product, a standard tablet formulation, in its main markets USA and in the EU within the rather short time frame of 18 to 24 months, respectively. The current registration issues established in the USA, Europe and Japan as a future market, which set an important time frame for the planning of the marketing activities, are also discussed and assessed.

In general, especially for generic companies, it is recommended to ensure a close and effective cooperation between all involved company departments. The necessary priorities have to be set and communicated clearly.
Special importance is attached to the regulatory affairs department. It is to analyse the current regulatory requirements, to observe any further changes and to evaluate opportunities for the company on an ongoing basis. Therefore, Regulatory Affairs should be involved already in the early steps of the product development and monitor each product over the entire life cycle, especially in the market introduction process.

Pages: 63