ESO Task Force for the definition of the position and role of 'Biosimilar' medical products in oncology
Over the past two decades, the United States and Europe experienced a dramatic and unsustainable rise in cancer health care costs. Eight of the top ten most expensive drugs are cancer drugs, notably the novel biologic agents arising out of the recent revolution in our understanding of the genetic and molecular basis of malignancy. As the protective patents on new biologic therapies reach expiration, the race to develop biosimilars has begun, hopefully increasing competition and reducing costs. Although the U.S. Food and Drug Administration (FDA) and the European Medicine Agency (EMA) have developed regulations for the development and approval of biosimilars, it remains uncertain how rapid and broad their entry will be. The reasons for such uncertainty are multiple but fundamentally relate to the biologic nature of these agents: these drugs, unlike generic pharmaceuticals, are large, complex molecules derived from biologic processes that are similar but not identical to the original agent and, thus, subject to immunogenicity and drift over time. The demonstration of comparable efficacy and safety to the originator is a challenge for both regulators and companies, necessitating careful pharmacovigilance following approval.
The Task-Force intends to discuss the FDA and EMA guidelines on biosimilars with the aim to provide an expert discussion on opportunities and misconceptions around development and use of biosimilars in cancer care. All non-clinical and clinical issues that may derive from their use in daily practice will be among the topics of the Task Force discussion in order to provide a balanced and unbiased position on all opportunities that may evolve from biosimilar use across cancer care.
- It is expected that the draft conclusions of the Task-Force will consequently be discussed in virtual meetings and the final results will be defined by the second quarter of 2017. The ESO Task-Force position paper will be published in a renown international scientific journal by the end of 2017. Preliminary consultations with The Lancet and Lancet Oncology will start in the near future.
- Furthermore, depending on the results, an educational course or conference is planned to be organised in 2018.
The Task Force
The task force is chaired by Giuseppe Curigliano (IT) and Matti Aapro (CH).
Members of the expert group are:
Dirk Arnold (DE), Fatima Cardoso (PT), Lucia Del Mastro (IT), Mario Dicato (LU), Jospeh Gligorov (FR), Michael Muenzberg (DE), Francesco Pignatti (IT), Huub Schellekens (NL).
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Pfizer and Sandoz, sustaining members of the Sharing Progress in Cancer Care (SPCC) programme, have provided an unrestricted grant towards ESO for this initiative. SPCC is a pioneering partnership between the European School of Oncology (ESO) and some of the world’s leading pharmaceutical companies.