On March 28th and 29th more than 140 experts in the field of pharmaceutical medicine gather in Berlin for the annual DGPharMed meeting on current trends in clinical drug development and regulatory affairs. This year’s meeting is placed under the topic of “Access to new therapies: from challenge to solution”. The meeting started with a very detailed and informative presentation from Dr. Elena Wolff-Holz from the Paul-Ehrlich-Institute (PEI) who is directly involved in the assessment of market authorizations for biosimilars. Dr. Holz presented the PEI’s position and appraisal criteria in the process of evaluating biosimilars. She gave a very positive picture of the overall quality of biosimilars and their clinical data. All in all there are more than 50 biosimilars approved in the EU and regulators encourage the industry to proceed with the development of new biosimilars.
Biosimilars are one important topic of the conference, accompanied by topics like paediatric drug development, big data, the new medical device regulation in the EU and the use of medical devices in clinical trials.