– The hospitals can save 750 million NOK yearly

Medical director Steinar Madsen at Norwegian Medicines Agency (NoMA) has been a proponent for biosimilars for many years. He received the results of the Nor-Switch study with great interest:

– Nor-Switch confirms that it is safe to switch, a view that we have held since 2010 at the NoMA. There are now several studies on switching from original drug to biosimilar infliximab or etanercept. There are also studies with multiple switches between original and biosimilar etanercept with the same clinical efficacy. There is no data to suggest that switching is no problem, Madsen comments to the Norwegian newspaper Dagens Medisin (Medicine Today)

Madsen originally proposed to do an independent, randomized switch study in Norway.

– Why was it necessary to carry out the study?

– We were unsure on the uptake of biosimilar infliximab in the clinic. Opposition to biosimilars - especially from the pharmaceutical industry - was significant. So we thought that a completely independent study could help to create confidence among doctors. In retrospect, it turned out that the concern was unwarranted in Norway. The use of the biosimilar infliximab increased rapidly and after two years has a market share of over 90 percent. In other parts of the world have there been greater scepticism and I think the Nor-Switch will become more important in countries other than Norway.

– What are the implications of the study?

– There is ample evidence that biosimilar drugs are as good as the original drugs. In the years ahead, we will have a number of new biosimilar drugs. If we utilize these drugs optimally, we can save an estimated 750 million NOK yearly. We need a system that ensures rapid switch to the least expensive drug – whether biosimilar or original drug.

– To what extent do you think the results can be transferred to other biosimilars?

– We now have so much experience that we need to put the question of switching behind us. There is no scientific basis that switching will cause problems.

– Do you think sales of biotilsvarende to Enbrel will increase by Nor-Switch performance?

Biosimilar etanercept (Benepali) has a market share of approximately 65 percent in Norway. However, some hospitals do not switch. We need a better system to achieve faster switching and thereby increase savings. Here we can learn from Denmark where a national system is in place and the market share of biosimilar etanercept is around 90 percent after just half a year, Madsen anwers.