Biosimilars: Shaping the Future of Haematology

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.