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Biosimilars in established rheumatoid arthritis

Interview with Prof. John Isaacs at EULAR 2016, London

Transcript

Q. John, thank you so much for joining us this afternoon to talk about biosimilars and particularly integrating biosimilars into the treatment of established RA patients with still disease activity.
A. My pleasure.  My name is John Isaacs as you know.  I am Professor of Clinical Rheumatology at Newcastle University and I am a consultant rheumatologist at the Newcastle-upon-Tyne Hospitals NHS Foundation Trust.

Q. You ran a symposium at EULAR on biosimilars. What are the key learnings?
A. Okay. Obviously the really positive thing about biosimilars is that they are going to push the price of biologics downwards and in a sense we have been waiting for this for many years, because we know these are good drugs and whichever class you choose our patients do well, but access is limited because of the cost.  The cost is fair enough – they are expensive to develop, so I have no issues with the cost, but now patents are running out, biosimilars are coming along and that will push down the cost. 

The issues around biosimilars, for the last couple of years, has been that they are not generics.  Unlike a small molecule drug you cannot exactly copy a biologic, it is just not possible because they grow in cells and any vial of the biologic contains many different related species, so it is impossible to have an identical copy.  That has caused, I think, concerns, partly because of lack of education if you like.  We have not really understood biologics to that degree because it has not been necessary, but with the advent of the biosimilars we now recognise how it is possible to characterise a biologic drug and of course the biosimilar pathway puts a lot of emphasis on the analytical aspects of the biologic, the comparability between the originator and the biosimilar in terms of all sorts of things.  Not just in terms of its primary sequence but its post-translational modifications and I think essentially practising clinicians can now be reassured that the pathway for the development of a biosimilar is very stringent and although they don’t see much clinical data, that is predicated on the fact that if everything else is very similar in terms of the physical attributes and the analytical qualities, then it doesn’t need a big clinical trial; the clinical trials are only there to iron out any final uncertainties.

The other thing that has changed attitudes is a realisation that even the originator biologics have to go through what we call comparability exercises.  A lot of practising rheumatologists probably don’t realise that, for example, the infliximab they used 15 years ago is not exactly the same as the infliximab they used today because the manufacturers improved their processes in all sorts of ways.  Therefore it is unfair to say infliximab is a biosimilar really, but it is different; it is not the same as the one we used to use.  As people have come to realise that then the whole concept of biosimilars makes more sense and, indeed, the regulatory pathway has been very much based on the comparability exercises that manufacturers have had to go through every time they have changed their originator in a significant way.  It is just a new era.

Q. The opportunity for the practising rheumatologists around the world in treating established RA patients who still have a lot of disease activity seems to present itself.
A. I hope so.  We all hope that.  The UK is a good example where we can only use a biologic when a patient has a DAS score of 5.1 and we are all hoping that, if the price of the drugs comes down then we might be able to reduce the DAS, so perhaps we are more aligned with other countries in the world and the same will be true in other countries.  It is hard to use a biologic off – I don’t mean off-licence, but for related areas; sometimes we think it would be useful to use a biologic in another space, for example.  Certainly where I come from that is very difficult.  Even if you make a rational case it is hard to do that, but if the price comes down it will be possible to do small trials and experiments to use drugs in those situations.  There is a great opportunity.

It is interesting, even what we all “transitioning”, so a patient who is on an originator, even at this meeting I have heard people start to talk about “Yes, I do understand why it might be reasonable to transition to the biosimilar”, whereas a year ago people would say “I will only use it for a naïve patient who has never had a biologic”.  Clearly attitudes are changing; I am not pushing one or the other, but I just hear people talking about it and so clearly people are feeling more comfortable, recognising that these are unlikely to be very different in real practice, but we have to be cautious.  We have to follow the patients.

Some of the problems will come around pharmacovigilance because of course if you end up having five or six biosimilars of an originator you need to know which one you are using, you need to know the batch number and again, the regulations have changed so we do need to record the batch number of the biologics and that is all to do with pharmacovigilance, so there will definitely be challenges, but ultimately it should increase accessibility for the patients which is our end game.

Q. Anything else in terms of cautionary notes for practising rheumatologists as they develop their own experience?
A. The main thing is you need to distinguish biosimilars from other drugs like biomimics.  There are other drugs out there which haven’t gone through the same regulatory process – probably not in Europe or in the US, but in other countries and so a biosimilar is a biosimilar because it has been through the regulatory process.  You need to be aware of that.  As I say, the pharmacovigilance is important. We don’t expect to see big differences. The sorts of things that are being recorded, things like immunogenicity for example, which doesn’t seem to be a big problem and then in some ways there is no reason why it should be a big problem, but there is no reason why you shouldn’t treat a biosimilar like any other new drug that you are using.  When you use it for the first time you want to make sure you collect as much information as you can.  If you have access to registries make sure you register your patients with the registry and treat it as if it is a new drug.

Q. Is it a lot of extra work?
A. I don’t think so.  The only extra thing is recording batch numbers; probably largely your pharmacist will help you with that and there will be strategies in place at each location to make sure that is collected.  I don’t think it is a lot of extra work.  If you are using a new biologic you would register your patient and make sure the data is captured.  We should be doing that anyway, even with the originator biologics; even now, 10 years down the line, we are still capturing those data.

Q. Okay. I hope that information does give our practising rheumatologists courage.
A. Thank you.

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