Regulatory Approach for Non-Biological Complex Drugs
- At: 2012 FIP Congress in Amsterdam (the Netherlands)
- Type: Poster
- By: BORCHARD, Gerrit (University of Geneva, School of Pharmacy Geneva-Lausanne, Geneva, Switzerland)
- Co-author(s): Flühmann, B. (Vifor Fresenius Medical Care Renal Pharma Ltd., St. Gallen, Switzerland)
Mühlebach, S. (Vifor Fresenius Medical Care Renal Pharma Ltd., St. Gallen, Switzerland)
In the European Union,..
of originator medicinal products are categorized either as generics or biosimilars and two distinct regulatory pathways have been established for marketing authorization. The major difference between the two product classes refers to the fact that complex biological molecules cannot be fully characterized and The access to the whole abstract and the presentation file is available to FIP members and to congress participants of that specific congress.