A recent position paper, published by the European Society for Medical Oncology (ESMO) has stated how biosimilars can create opportunities for sustainable cancer care.
Cancer Treatment
The paper highlights the potential benefits that biosimilars can provide for patients and healthcare systems, whilst also outlining how to safely introduce them into the clinic and the approval standards needed. ESMO also looks at issues surrounding biosimilars such as definition, labelling, extrapolation, interchangeability, switching and substitution.
Biosimilars are medicinal products that contain a similar version of the active substance as the original biologic. Unlike generics, which are identical copies of the original drug, biosimilars require clinical studies to ensure that the manufacturing process is genuine and identical to that of the original biologic. The paper states that optimal safety and efficacy is the shared responsibility of both the manufacturers and the regulatory bodies.
In Europe, potential savings of €50 - €100 billion have been forecast by 2020 for biosimilars, with price reductions expected to range from 20-40%. Biosimilars could have a big impact on the oncology landscape, due to the majority of monoclonal antibodies coming off patent by 2020.
Josep Tabernero, chair of the ESMO Cancer Medicines Working Group said: “Biosimilars are an excellent opportunity to have good, valid drug options that improve the sustainability and affordability of cancer treatment in various countries. To do that we have to be sure that biosimilars follow appropriate manufacturing procedures, are clinically tested, and adhere to regulations from the European Medicines Agency (EMA).”
Fortunato Ciardiello, ESMO president said: “Biosimilars are must-have weaponry in financially sustaining healthcare systems on a global scale as well as significantly improving outcomes for an increasing number of patients throughout Europe and the rest of the world.”
Tabernero said: “ESMO calls for strict adherence to approval standards of biosimilars as well as their accelerated introduction into the clinic. Aligned with ESMO´s mission to facilitate equal access to optimal cancer care for all cancer patients, and as clearly set out in its 2020 Vision, this paper provides a timely overview on where we are and the ‘where to next’ for biosimilar products and their respective regulatory approval processes.”
“The paper highlights a number of areas that should be carefully considered by all stakeholders including prescribers, pharmacists, nurses, patients, reimbursement bodies, and manufacturers. Importantly, it also outlines a number of directions that will need to be collectively followed to guarantee the highest safety and efficacy standards of these medicines and ensure that all patients, irrespective of geographical borders, can access the very best evidence based treatments.”
“Biosimilars give us the chance to make treatment options for cancer more affordable everywhere,” the ESMO President said. “This ESMO position paper sets out a series of principles that should be fulfilled to ensure that the biosimilars that reach the market are of good quality, safe and effective. Clinicians are starting to ask questions about how to incorporate biosimilars into their daily practice and until now they did not have an authoritative source of information. This paper serves to educate practising physicians on this complex topic.” Tabernero said.