Getting generic pharmaceutical products developed and registered is associated with specific challenges. The task is not only to copy the innovator product and apply for marketing approval in common and established procedures. The challenge starts already with the identification of possible target products. Real innovative pharmaceutical products with huge market potential have to be identified sometimes even before the originator launches its product. A key success factor for generic companies securing their own feasible development strategy is to apply for their own patents already in this stage. Thus, the generic’s development may start in a situation of ambiguity caused by the originator product not yet being marketed in the EU.
Another challenge is related to the fact that the development goal for a generic is not “the best” formulation of a drug product, but a formulation which is exchangeable (“essentially similar”) with the reference product of the originator. Formulation patents or patents related to particle size distribution of the active pharmaceutical ingredient filed by the originator complicate the pharmaceutical development of generics further.
From today’s perspective it seems surprising that generics were introduced in Europe in the early 1970s but a legal definition for this product category was not introduced before 2004, in the Review 2001 process. The overall goal during the Review 2001 process was to create a balance between fostering innovation throughout the EU and cost containment in the healthcare system. Meanwhile, many guidelines were developed dealing specifically with generic pharmaceutical products. Simultaneously with the legal definition of generic medicinal products, two other product categories were legally defined and differentiated from generics: pharmaceutical products requiring hybrid applications and biosimilar products.
The marketing authorization procedures for generics in the EU are generally the same as for any other pharmaceutical product. Nevertheless, there are specific topics to be considered in relation to the access and applicability of each procedure as well as inclusion of generic-specific documents into the CMC dossier. The first task is to identify the appropriate reference product and the correct data exclusivity period, which starts with the first approval of the innovator product in the EU. Regulatory authorities have a close look at data exclusivity, because they can be sued if they do not carefully check the information provided by the generic applicant. In contrast to the US, the patent situation is out of scope of the regulatory authorities in the EU. Planning the marketing authorization procedure and launch of a generic has to deal with both aspects: data exclusivity and patents. Mistakes here can have major economic consequences. Filing later than the generic competitor will lose the generic applicant valuable time in the early generic marketing phase. Launching a generic and not respecting all relevant patents results in costly court cases and often withdrawal of the generic product from the market.
The course will describe in detail the development and regulatory environment for generic pharmaceutical products in the EU. A special focus will be dedicated to the CMC dossier (Module 3) and to generic-specific aspects of the procedures to obtain and maintain marketing authorizations.