Utilization of biosimilars has the potential to overhaul cancer treatment.
Biosimilars have the opportunity to provide affordable, effective drug therapy for patients with many different diseases, including cancer. The European Society of Medical Oncology (ESMO) recently published a position paper in ESMO Open that discusses how biosimilars have the unique possibility of creating sustainable cancer care.
“Biosimilars are an excellent opportunity to have good, valid drug options that improve the sustainability and affordability of cancer treatment in various countries,” said Josep Tabernero, MD, PhD, chair of the ESMO Cancer Medicines Working Group. “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).”
All regulatory agencies, including the FDA, and manufacturers must collaborate to ensure that patients are receiving safe and efficacious biosimilars.
Biosimilars are products that are highly similar to a reference product, which is a biologic drug derived from living organisms. These products differ from generics since they are not identical, and must undergo clinical trials to ensure that manufacturing processes are stable, and the product does not deviate from the reference product, according to the article.
In Europe, biosimilars are expected to reduce costs up to 40% compared with the reference product, while they are expected to be reduced up to 30% in the United States. Although most insurance companies pay for a large sum of oncology drug costs, patients may face financial barriers that prevent them from obtaining the necessary care under the current system. With discounted biosimilars, this may not be an issue.
Since a large portion of biologic drugs are expected to come off patent by 2020, biosimilars may have a chance to significantly improve oncology care.
“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,” said ESMO President Fortunato Ciardiello, MD, PhD.
The position paper considers multiple barriers facing biosimilars, including definitions, labeling, extrapolation, interchangeability, switching, and substitution.
“ESMO calls for strict adherence to approval standards of biosimilars as well as their accelerated introduction into the clinic,” Dr Tabernero said. “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.”
While the uptake in biosimilars has been relatively slow, more are receiving regulatory approval. In the United States, 4 biosimilars have been approved, with numerous candidates still undergoing clinical testing. Allowing patients to access alternative cancer drugs will increase competition, and hopefully, lower costs as a result.
With the emergence of biosimilars, it is important that healthcare stakeholders, such as prescribers, pharmacists, nurses, patients, payers, and manufacturers, be aware of special considerations that may impact the utilization of the drugs, according to the article.
“Biosimilars give us the chance to make treatment options for cancer more affordable everywhere,” Dr Ciardiello concluded. “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 [sic] physicians on this complex topic.”