Biosimilars Create Opportunities for Sustainable Cancer Care

ESMO position paper offers important advice

A new position paper from the European Society for Medical Oncology (ESMO) outlines approval standards for biosimilars; how to safely introduce them into the clinic; and the potential benefits for patients and health care systems.

“Biosimilars are an excellent opportunity to have good, valid drug options that improve the sustainability and affordability of cancer treatment in various countries,” said Professor Josep Tabernero, chair of the ESMO Cancer Medicines Working Group.

Biosimilars are medicinal products derived from living organisms that contain a similar version of the active substance as the original biologic. They differ from generics, which are chemically synthesized and are identical copies of the original drug. Unlike generics, biosimilars require clinical studies to ensure that the manufacturing process is sound and does not differ from that of the originator biologic.

Most monoclonal antibodies are set to come off patent by 2020, which will open the door for biosimilars and could dramatically change the oncology landscape, according to the ESMO document.

“The paper highlights a number of areas that should be carefully considered by all stakeholders including prescribers, pharmacists, nurses, patients, reimbursement bodies, and manufacturers,” Tabernero said. “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.”

He continued: “Biosimilars give us the chance to make treatment options for cancer more affordable everywhere. 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 practicing physicians on this complex topic.”

Key topics covered in the document include:

  • Labeling of biosimilars
  • Extrapolation
  • Interchangeability, switching, and automatic substitution
  • Clinical standards: safety and efficacy of biosimilars
  • Responsibilities between prescribers and pharmacists

ESMO is the leading European professional organization for medical oncology, with more than 15,000 members in more than 130 countries.

Sources: ESMO; January 18, 2017; and ESMO Open; January 16, 2017.