Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Comparison of the regulatory requirements for the proof of comparability of generic locally applied locally acting products with their originator product in the EU and USA - an overview on the current status and the latest trends

Yvonne Hinterstocker (Abschlußjahr: 2023)

Summary
Language: English
The regulatory regions USA and EU define a generic medicinal product as a product that has the same qualitative and quantitative composition as the reference medicinal product. Its bioequivalence with the reference product has been demonstrated with bioavailability studies.
For the generic medicinal products addressed in this work it is not possible to demonstrate bioequivalence with bioavailability studies as the products are acting locally at the site of their application. Generally, a bioequivalence of these products can be established with clinical trials and therapeutic equivalence studies. These clinical trials are a huge time and cost factor for the development of generic medicinal products.
Thus, efforts have been taken in the US and the EU to provide guidance for alternative methods to establish bioequivalence for these product groups and avoid clinical trial testing.
This work addresses the existing and drafted regulatory framework provided for both regulatory regions by assembling and evaluating the published guidance documents in the US as well as the EU. A comparison of the current framework for both regions is given.
Furthermore, the regulatory praxis and the utilization of the provided guidance by the pharmaceutical industry in both regions is evaluated. Databases such as the PSG database of the FDA as well as the PAR in the EU are screened and evaluated regarding the utilization of alternative methods to demonstrate bioequivalence of locally applied locally acting medicinal products.
Overall, an evaluation of the current methods and possibilities to establish bioequivalence during the development of locally applied locally acting products is made. The currently ongoing drafting of guidance documents in the US as well as the EU are highlighted and summarized.
Pages: 48
Annexes: 9, Pages: 54