Preparing for the incoming wave of biosimilars in oncology

Abstract

With the imminent arrival of oncology biosimilars in the therapeutic paradigm, stakeholders including a clinician, specialist nurse, patient advocate, regulator and economist provide their perspective on optimising the uptake of these new agents in the treatment of cancer. A number of key messages emerge, based on the discussion that took place during a session of the European Society for Medical Oncology’s Annual Congress, ESMO Madrid 2017. First, for successful integration of biosimilars into the global healthcare paradigm, informing and educating the full scope of stakeholders, including clinicians, nurses, pharmacists and patients, is primordial. Success is dependent on providing solid evidence and ensuring all voices are heard. Second, for oncology medicines, much can be learnt from the growing experience of approved biosimilars in other disease indications, with success stories for patients, their healthcare providers and healthcare budgets alike. Finally, effective sustainability of the impact on healthcare budgets and the redirection of these savings require education and transparency.

European Stakeholder Learnings Regarding Biosimilars: Part I—Improving Biosimilar Understanding and Adoption

“…These recommendations can inform policy making and other stakeholder initiatives to increase biosimilar understanding. As recognized by the interviewees, extensive efforts have been made by European regulators to provide clear information regarding biosimilars and the science behind the regulatory evaluation to the public [2,[52][53][54][55][56][57]. Investments in providing unbiased biosimilar information and conveying trust in the regulatory evaluation must be continued (recommendation 1) to further improve stakeholder understanding.…”

Cancer medicines in Asia and Asia-Pacific: What is available, and is it effective enough?

“…The clinical value of a biosimilar is equal to the originator medicine, and it is estimated that the use of biosimilars can create a potential savings for cancer medicine expenditures in the USA and the European Union of 100 billion Euros by 2020 45. The lower cost of biosimilars represents an opportunity to reshape the market and introduce competition to the originator medicine, thereby impacting the financial burden of cancer 46…”

RGB-02 (Biosimilar Pegfilgrastim) In The Treatment Of Chemotherapy-Induced Neutropenia

“…The regulatory process of biosimilar approval in Europe was established earlier than in the USA. Since 2001 when biosimilar legislation emerged >50 biosimilars corresponding to 25 distinct agents have been authorized by the EMA, most of them being approved in recent years [38]. Further rapid increase in number is foreseen for the year 2020 when widely utilized originator biologics will lose their patent exclusivity.…”