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The advent of biosimilars is a true revolution in oncology, pursuing a more sustainable healthcare around the globe. When issues of financial toxicity are faced by many patients precluding the access to the most valuable medicines, improvement of cost-effective cancer interventions can play a key role in enhancing equity - reducing the survival gaps related to inequalitues across the cancer continuum. This volume on biosimilars is conceptualized around three basilar topics in the field: methodologies and approaches for the similarity exercise, the central concept and implications of extrapolation, the experience in clinical practice with biosimilars and the regulatory pathways for approval and market authorization - including the benefits in the authorization and use of biosimilars. All the chapters aim to provide differentiated perspectives, for clinicians and health professionals including cancer nurses, pharmacologists and pharmacists, advocacy and policy-makers, built in a patient- centered perspective, to ensure a comprehensive and inter-sectoral multi-stakeholder approach. With the intention to improve the affordability of essential medicines for cancer management, biosimilar retain the huge potential to prioritize cancer care in all the countries, helping leaving no one behind when facing a diagnosis of cancer - expecting benefits for patients, health systems and the overall societies. If a revolution in cancer care can be stated, is when all the patiens are secured with the best treatment options available, prioritized per valute, capable to improve efficiency in health investments and resource-utilization.
Introduction
Francesco Scaglione, Dario Trapani, Giuseppe Curigliano
Pharmacological approaches to demonstrating biosimilarity
Francesco Scaglione, Arianna Pani
Clinical approaches to demonstrating and evaluating biosimilarity
Carmen Criscitiello, Giulia Viale
Principles of extrapolation
Dario Trapani, Giuseppe Curigliano
Experience of biosimilars in oncology
Lucia Del Mastro, Giulia Buzzatti
The regulatory pathways for biosimilar approval
Sandra Petraglia
Conclusions
Francesco Scaglione, Dario Trapani, Giuseppe Curigliano
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