Biosimilars: Designing and Building the Clinical Package 2015

The patent expiry of a number of biologics that have revolutionised medical practice is imminent. Numerous programs have been initiated to develop corresponding follow-on products. Regulatory agencies have issued guidance on abbreviated clinical requirements for marketing authorisations tailored to such replicates.

This workshop will provide a detailed overview over the thinking behind the abbreviated clinical evidence base, and the purpose the different components serve. The Master-class will speak to aspects such as the “sensitivity” of the selected clinical model, the role of clinical evidence in the “totality of evidence”, as well as operational aspects of the clinical trials. As product safety plays a central role in stakeholder expectations particular attention will be given to means to address this important topic.

Why you should attend:

Biosimilars has become a very active and exciting arena.
This masterclass will give you valuable insights into the principles that shape this space, including its challenges and opportunities
Network with your peers and gain new and valuable insights

Hosted by: Uwe Gudat, Head of Safety Biosimilars, Merck Serono