The authors of a European review provide recommendations for all stakeholders on smooth implementation of cancer biosimilar agents.
Oncology clinicians and other stakeholders can put into practice three key messages to ensure the success of oncology biosimilar agents, according to a review article published in ESMO Open.
The state of biosimilars in Europe is about 10 years ahead of the United States, said Gary H. Lyman, MD, MPH, Senior Lead, Healthcare Quality and Policy at Fred Hutchinson Cancer Research Center in Seattle and a professor at the University of Washington School of Medicine, in an interview with Cancer Network. “There is a huge amount of biosimilar development in Europe and other parts of the world that we haven’t been able to take advantage of,” he said.
Beyond the advanced state of biosimilar drug development in Europe, the European Medicines Agency (EMA) is preparing for a swathe of new oncology biosimilar approvals in the coming years.
In 2017, the EMA approved 14 molecules versus no more than 5 approvals a year since 2006, when somatropin, the first biosimilar, was approved. Furthermore in 2017, the EMA approved the first oncology biosimilar monoclonal antibodies; oncology biosimilars have, until recently, been of lower priority. However, that has been changing, with several more such agents since approved: 6 rituximab biosimilars, 1 bevacizumab biosimilar, and 1 trastuzumab biosimilar, as well as 15 oncology biosimilar applications currently under consideration.
In the current review article, Wolf-Holz et al stress three principal messages to guide the success of oncology biosimilar drugs.
First, for biosimilars to be successfully adopted in the global healthcare setting, all stakeholders-including physicians, specialist nurses, pharmacists, and patients-need to be educated using solid, compelling data, including from clinical trials. These stakeholders must also be able to express their concerns.
“With over 10 years of safe and effective use of biosimilars, the EU has the largest biosimilar experience worldwide,” wrote the authors. “As pioneers in this field, European regulators must keep in mind that compared with clinicians and patients, they have the advantage of a long history of biosimilar awareness. Their expertise is reassuring and certainly plays an important role in acceptance of these new agents.”
Second, with respect to oncology biosimilar agents, experts can learn from experiences with approved biosimilars for other serious illnesses, including successful accounts from patients and healthcare providers. Experts can also learn about the potential financial savings of biosimilars by comparison, the authors wrote.
Third, for sustainability and continued financial benefit, transparency and education are necessary. To be transparent, the EMA must disseminate information to two distinct audiences-the healthcare providers and the patients-that explains their calculus in approving the biosimilar, or, more specifically, how the benefits outweigh the risks.
The sustainability and low cost of biosimilars will ensure that even those patients in Europe who may not otherwise be able to afford optimum therapy will now be able to afford it, the researchers concluded.