This satellite symposium took place on 10th June 2016, as a part of the 21st Congress of the European Hematology Association (EHA) 2016 in Copenhagen, Denmark
Chairperson: Robin Foà1
Speakers: Armando López-Guillermo,2 Martin Schiestl,3 Steffen Thirstrup4
1. Department of Cellular Biotechnologies and Hematology, Sapienza University of Rome, Rome, Italy
2. Hospital Clinic, Barcelona, Spain
3. Sandoz GmbH, Kundl, Austria
4. NDA Advisory Services Ltd., London, UK
Disclosure: Prof Foà has received honoraria for advisory boards and has sat on speakers’ bureaux for Roche, Genentech, Janssen Pharmaceuticals, Gilead, Sandoz Biopharmaceuticals, Pfizer, Amgen, BristolMyers Squibb, and Celgene. Dr López-Guillermo has received honoraria for advisory boards and has sat on speakers’ bureaux for Roche, Janssen Pharmaceuticals, Gilead, Sandoz Biopharmaceuticals, Celgene, and Mundipharma. Dr Schiestl is a full-time employee of Sandoz International GmbH. Prof Thirstrup is a full-time employee of NDA Advisory Services Ltd.
Acknowledgements: Writing assistance was provided by Dr Blair Hesp CMPP of ApotheCom.
Support: The symposium was jointly sponsored by Hexal AG and Sandoz International. Authors received honoraria for preparation and delivery of their presentations. The views and opinions expressed are those of the authors and not necessarily of Hexal AG or Sandoz International GmbH.
Citation: EMJ Hematol. 2016;4:30-37.
Prof Robin Foà opened the symposium by highlighting how improving healthcare and an ageing population are increasing the burden on healthcare resources and creating challenges in maintaining the high level of healthcare provision that many people expect. Dr Armando López-Guillermo discussed the role of biosimilars in maintaining sustainable and affordable healthcare systems and the need to balance this against ensuring that biosimilars offer comparable efficacy and safety compared with their reference products. Dr Martin Schiestl outlined the differences in approval processes for biosimilars compared with novel biological therapies and generic versions of small-molecule drugs, and how this ensures similarity between biosimilars and their reference products. Prof Steffen Thirstrup reviewed the processes that European Union regulatory authorities undertake when deciding whether it is appropriate to extrapolate indications for biosimilars beyond a single approved indication. The meeting objectives were to discuss the role of biosimilars in meeting healthcare needs and to review what regulatory assessments biosimilars undergo prior to receiving marketing approval, and how additional extrapolated indications can be scientifically justified.