Biosimilars are as safe and efficient for use as cancer medication as the original

Biosimilars should be easier to bring to market, suggest researchers in Lancet

Biosimilars are biological medications made on the basis of  an original drug for which the patent has expired. As a result, biosimilars are far less expensive than patented medicines. However, biosimilars must still be individually tested before they can be brought to the market. Huub Schellekens (Pharmaceutical Sciences) and his American and European colleagues are of the opinion that over the past 10 years, biosimilars have been sufficiently proven, so it should be made easier to bring them to market. This would dramatically reduce the cost of health care. Their research was published in Lancet on 2 November as a series of three articles on the safety of cancer medication in general.

Before a biosimilar reaches the market, it is of course necessary to prove that its safety, quality and effectiveness is comparable to the original drug on which it is based. The researchers state that oncological biosimilars that can be analytically shown to be closely similar to the original medication need less exhaustive clinical tests. They base their claim on the successful introduction of dozens of other biosimilars over the past decade. 

Huub Schellekens
Huub Schellekens

Commonly used in Europe

Schellekens also shows that biosimilars are safe and effective, and are already commonly used throughout Europe. But the use of the drugs still lags behind in the United States, because the patents there expire later and regulation has not been implemented as quickly. There is some question as to whether biosimilars would be used very often in the US as well. In most European countries, it is easier for the government to require the use of biosimilars that are just as effective, but much more affordable.

Utrecht Centre of Excellence for Affordable Biotherapeutics

Huub Schellekens has worked on biosimilars for quite some time, and is the Director of the Utrecht Centre of Excellence for Affordable Biotherapeutics (UCAB). In this position, he is currently working on the introduction of two biosimilars to the market. As biosimilars are so much cheaper, he mainly focuses on low- and middle-income countries, where many people cannot afford standard medication.


Huub Schellekens*, Josef S. Smolen, Mario Dicato, Robert M. Rifkin
Safety and efficacy of biosimilars in oncology, The Lancet Oncology, November 2016
* Affiliated with Utrecht University