How can we integrate biosimilars into clinical practice?

Biosimilars have the potential to extend cutting-edge, affordable, sustainable cancer treatment to a wider range of individuals. It is in the interest of patients and healthcare systems that these agents are effectively incorporated into clinical practice.
But it is not as easy as it seems and many challenges pose significant limitations.

What are biosimilars?

Biosimilars are biological medicines that are very similar to another already approved biological medicine. They must undergo the same rigorous process of any drug to receive marketing approval.

The first biosimilar was approved in Europe in 2006.

In 2016, biological medicines accounted for almost 40% of the entire EU spend of €24.2 billion on cancer treatments (Wolff-Holz et al. 2018). However, the biosimilar market share of the biological medicines used in oncology is still low (around 11%) and costs per treatment day vary across European markets (from -15% to 14%), indicating considerable room for expansion.

What ESMO recommends

In 2017, a position paper on biosimilars was published to support their use in oncology to achieve sustainable cancer care and accessibility to optimal cancer care. Lack of data regarding their interchangeability with the reference medicine was presented as one of the major issue for their integration in clinical care.

In 2018, a second paper outlined the relevance of lessons learnt with the use of biosimilars in other diseases, and key role of education and collaboration among all stakeholders—prescribers, pharmacists, nurses and patients—in order for biosimilars to become integrated into routine oncology practice.


Elena Wolff-Holz

Paul-Ehrlich-Institut, Langen, Germany; European Medicines Agency Committee for Medicinal Products for Human Use (EMA CHMP) Biosimilar Medicinal Products Working Party Chair


Johan De Munter

University Hospital Ghent, Belgium; European Oncology Nursing Society Board Member and Communication Working Group Chair


Doris C. Schmitt

Medical Writer, Communication Trainer and Patient Expert in Breast Cancer, Konstanz, Germany


Harbans Dhillon

Kuala Lumpur, Malaysia; International Society of Oncology Pharmacy Practitioners Past President