I had the honour to present at one of the satellite symposia regarding biosimilars. We were talking about prescribing with confidence. The situation is that we have approved biosimilars in the US and in Europe and in many countries in Europe we already have quota. What we see regarding the uptake of biosimilars in the clinical market is that there are hospitals or even chains of hospitals where pharmacists are deciding, with or without the influence of doctors, to completely switch to biosimilars wherever a biosimilar is available. That puts the doctors in a difficult situation because many of them have not really taken time to look at data regarding biosimilars. Many doctors have a problem understanding what discriminates a biosimilar from a generic drug. So the problem is they are using a therapy for a patient because of a need, because they have no other chance, but they are not really confident that they’re doing the right thing. That is actually one of the points of the people who are doing a lot of work on biosimilars and we published a paper in Lancet Oncology this year regarding biosimilars, preparing a review for the oncologists at the moment. So the idea is we have to tell people about the clinical data because prescribing is about confidence and if you’re not confident you’re doing the right thing that is an ethical dilemma but actually it is not because biosimilars are biosimilar because they have the same pharmacokinetic, pharmacodynamic and clinical features and efficacy and actually they are interchangeable.
There’s another point that is very important to understand for doctors, it’s allowed to extrapolate from indications. So, one example, three biosimilars for trastuzumab have been in clinical trials for PCR for breast cancer in the neoadjuvant setting but they have an approval for metastatic breast cancer and also for metastatic HER2 positive gastric cancer. That is, of course, not random, it’s not just because the originator has the same indication that it’s working but you have to show that it’s the same mechanism of action but you do not have to show clinical data for that. That is very unusual in our world, we are always used to having drugs that have clinical trials in an indication and then we use it in that indication. What is important to understand for the doctors is that the biosimilar is literally nothing different, it is trastuzumab. That is that the side effects are the same, the immunogenicity, that is what many people are concerned of, is the same and that we really can interchange them or exchange them if we want to.
One thing is, in my opinion, very important and that is that it should not be, and I said it in the beginning, that in some settings the pharmacists are deciding that. I do believe that the doctors have to be part in that process because of the confidence they have in the treatment they’re giving a cancer patient. So I believe that the most important thing at the moment is now that we have approval for biosimilars for a cancer therapy for trastuzumab is doing education, education and education, making people familiar with the clinical data, making people familiar with the approval process but with that concept of totality of evidence so that in the end they understand that it’s actually the same medication and they should not have any worries replacing one by the other. That is a process that is just now starting because the market uptake is not proportional to the confidence doctors have in biosimilars.
So it’s not that there is a resistance to biosimilars, there just isn’t the understanding generally.
Actually in clinical words, yes, there is a resistance but it’s not a resistance because people have taken pains and went into the clinical data but they’re just not aware of the process. I’m talking to many people and a lot of people, renowned oncologists, have not even thought about the difference between a biosimilar and a generic drug. We all have loads of things to do, we have loads of new data, maybe that’s not actually the focus point for many people, but one thing is for sure, many questions about biosimilars have to be clarified – what is the manufacturer one personally has confidence in and things like that. But there are two things that definitely can be taken for a given. One thing is nobody who is doing oncology can in the end, in the long run, avoid biosimilars so we will have to think about them. The second thing is biosimilars are making expensive biologicals cheaper and from an ethical standpoint broaden the access all over the world, maybe even in regions where biologicals were not available yet. So it’s in the interests of patients all over the world they’re a good thing.