Challenges of marketing authorisation and change procedures for generics in 2020


Published 2 March 2020


Dr. Helmut Vigenschow
Pharmaceutical Consultant

The Marketing Authorisation & Change Procedures for Generics course is a perfect opportunity to receive insight into the entire lifecycle of generic medicinal products starting from identification of the most promising development candidates, performance of the development, filing successfully marketing authorization applications up to maintaining the state of regulatory compliance for the product on the market. It is designed for scientists starting their career in this field and for experts already working on specific topics of this development process who want to close gaps in related areas. New guidelines like ICH Q12, ICH Q14, revision of the Environmental Risk Assessment guideline and recent requirements like Elemental Impurities or N-Nitrosamine risk assessments are covered as well. This is the reason why this course will be an ideal opportunity for leaders and department heads to update their knowledge to the current state. The goal is to create an interactive atmosphere where each participant receives advice on specific questions.

The task to identify and register generic pharmaceutical products is associated with specific challenges. It is not only to copy the innovators product and to apply for marketing authorisation in common and established procedures. The challenge starts already with the identification of possible target products. Truly innovative pharmaceutical products with a huge market potential have to be identified as early as possible. It is a key success factor for generic companies to secure an own feasible development strategy already in this stage by own patent applications. Thus, the generic development starts in a situation of ambiguity which is related to the fact that the originators product in some cases is not yet marketed in the EU.

Another challenge is related to the fact that the development goal for a generic is not “the best” formulation for 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 or even by a generic competitor complicate the pharmaceutical development of generics further.

From today’s perspective it seems surprising that generics have been introduced in Europe in the early 1970ies but a legal definition for this product category has been introduced not before 2004 after the Review 2001 process. One of the goals in this process was to create a balance between the wish to foster innovation throughout the EU and the need for cost containment in the healthcare system. Meanwhile, many guidelines have been developed dealing specifically with generic pharmaceutical products. Simultaneously to the legal definition of generic medicinal products, two other product categories have been 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 related to the access and applicability of each procedure as well as inclusion of generic-specific documents into the 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 products in the EU. Regulatory authorities have a close look on data exclusivity, because they can be sued if they do not check carefully the information provided by the generic applicant. In contrast to the U.S. FDA, the patent situation is out of scope of the regulatory authorities in the EU. Planning the marketing authorization procedure and the launch of a generic has to deal with both aspects, data exclusivity and patents. Mistakes here can have costly consequences. If the generic applicant files later as the generic competitor, he will loose 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 authorisations. Updates on new approved and draft guidelines and other specific regulatory requirements will increase the value for participants.