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Biosimilars: observational real-life data therapy

Interview with Prof. Tore K Kvien at EULAR 2016, London


Q. Tore, thank you so much for joining us for this brief interview to discuss one of the key presentations on biosimilars here at EULAR. Could you tell us a little more about the research you have been doing and in particular we would like our practising rheumatologists to become perhaps more confident about the introduction of biosimilars into practice.
A. First of all, thank you very much for inviting me.  My name is Tore Kvien. I am a rheumatologist. And also in Norway, I am Head of the Department of Rheumatology at the Diakonhjemmet Hospital, and Professor at the University of Oslo.  I will also mention that I am also Editor of the Annals of Rheumatic Diseases which perhaps sometimes biases me sometimes a bit about selection of articles. 

First of all, as I mentioned I am from Norway and biosimilars have a very important role in Norway over the last two years, because we had access to biosimilar, infliximab, from January 2014 and that was one year before the EU countries, because there were differences in Europe regarding the expiry, when the patent of Remicade expired. 

In Norway we have a tender system so every year the companies offer a price for the product.  This is a national system, so there is really a competition between the companies, as long as you know on a group level there is no evidence that there is a definite difference between the biologic DMARDs regarding efficacy, safety, which means that in Norway the price of the product is a very strong factor in the priorities regarding prescriptions. We make recommendations every year about starting with the new biologic DMARD or switching from one drug to another.

What happened in 2014 was that we got a very favourable price for biosimilar, infliximab, so that was the cheapest alternative among the TNF inhibitors and for 2015 we got an even lower price. What we then have seen is that the update of biosimilar infliximab has been considerable in Norway, so that has been the recommended TNF inhibitor or biologic DMARD when you start or change therapy in patients with rheumatoid arthritis and ankylosing spondylitis and psoriatic arthritis.

The market share of biosimilar infliximab compared to the originator product is now 90% biosimilar infliximab and what we have seen is also that the total use of infliximab has increased; it has doubled actually over the last two years.

What is also a major issue in Norway is that we have, as many other countries in Europe, a register, so we have also real-life data on biosimilar infliximab. When we look at the data it seems that drug survival safety and effectiveness is very similar to the originator products.  In Norway I think rheumatologists, but also gastroenterologists and dermatologists have a lot of confidence in using biosimilar infliximab and now also we have access to biosimilar etanercept, Benepali, from Samsung Biogen, SB4, which is also approved. SB2 biosimilar infliximab from Samsung Biogen is also approved by EMA but still not used.

The other important part in Norway is that there has been a lot of discussions about interchangeability and that is from an international level, so whether you can safely change patients on Remicade to biosimilar infliximab?  That was addressed by the Norwegian Government in their budget for 2014, so they allocated €2.5 million to do a switch study. We designed the NOR-SWITCH trial which was completed with the inclusion in June 2015 with 498 patients. The last patient out will be now, 15 June, and we will analyse the data during the summer and the plan is to submit late breaking abstract to the gastro congress in Vienna and to ACR so hopefully we will be able to present the results in November. We will, of course, write a paper about this.  That will not be the final answer to the question of interchangeability.

Q. It is long term maintenance is going to be very important.
A. Yes, and first of all it is a non-inferiority trial, we need to see the results. If the results are as expected you cannot necessarily extrapolate to other biosimilars so you need also more trials to explore this important issue about interchangeability.
In summary I think that confidence in biosimilars in Norway and some other European countries is really high. In Denmark for example it was also mandatory to switch patients from the originator to biosimilar infliximab because it was cheaper, but that was a decision that was driven by the payers, but the prescribing doctors they have been compliant to the requests from the authorities.

Q. On the SWITCH trial did you have any stopping rules that might let us know early whether there are any particular issues?
A. No.  We didn’t have that. It was powered to be a one-year study. The primary endpoint was disease worsening and the estimate was that that would occur in 30% of the patients. It is a non-inferiority margin of 15% and it is a power of 90%, so that was the power calculations.

Q. No safety signals at this point?
A. No, but we haven’t analysed anything yet and we will be very strict on not disclosing the results until we have completed the analysis in an appropriate way.

Q. Thank you very much. Anything else you would like to share with the practising rheumatologists about in their own practices?
A. I sometimes say that the question of biosimilars is more politics than medicine. You need to demonstrate comparability with your originator product, that is also a responsibility for regulatory agencies, but biosimilars should not be better, they should not be worse, but they should be cheaper. That is why I am saying that this is politics as much as medicine.

Q. No red flags?
A. No; not as far as we have seen.

Q. Thank you very much for joining us this afternoon.
A. Thank you for inviting me. 


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