• Understand the European concept of biosimilar medicinal products
• Regulatory requirements for biosimilars in EU
• Market uptake of biosimilars – learn from the Danish experience

 Seminar Chairs:

• Steffen Thirstrup, MD, PhD, Head of Institute, Institute for Rational Pharmacotherapy, Denmark
• Nanna Aaby Kruse, M.Sc.Pharm, Senior Biological Assessor, Member of BWP, Danish Medicines Agency, Denmark

Overview:

Biosimilar medicinal products – or short biosimilars – are a relatively new concept within the European regulatory framework. The concept has not yet been taken up by other major regulatory bodies such as the FDA, but is intensively discussed within industry. In the classical generic approach ‘essential similarity’, is often shown through Quality/CMC data and limited clinical data such as studies of bioequivalence. This approach is not sufficient for complex biological products. The EU legislation and guidance documents developed by CHMP and its working parties have tried to fill this gab. However, despite this effort numerous issues are still debatable and guidance is currently lacking for more complex biological products such as monoclonal antibodies. This one day seminar is an excellent opportunity to gain, from the regulatory Authorities, a short overview of EU legislation and related regulatory guidance regarding biosimilars. Especially the seminar intends to give the participants a better understanding of the regulatory considerations regarding the minimal requirements for new biosimilars. Moreover, the seminar intends to discuss topics not yet fully addressed by current guidance such as biosimilar monoclonal antibodies. Lastly the seminar will give an example of the market uptake and the obstacles experienced for biosimilar products in Denmark. 

Target Audience:

The seminar is open for anyone interested in gaining a broader knowledge on biosimilars, covering all part of the product development phase (quality, non-clinical, clinical and economical issues).

2 new modules: Veterinary Products & Genenic Products

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