Development of biosimilars for use in treating elderly patients
Dr Etienne Brain - Institut Curie, Paris, France
It was something quite new, we thought it was an important problem topic for the future. Why is that? Because biosimilars are a bit different from generics because the manufacturing process is slightly different and the rules and the regulations are different also because they require a long comparative process with the biopharmaceutical seminal initial to guarantee that they have the right quality, the right activity. It’s a bit different from chemical synthesis for generics because biosimilars are built, manufactured, through living organisms which yield a heterogeneous batch, they may be slightly different from the seminal compound and in this way it’s a bit different from generics. That’s why the regulatory issues and the rules around are probably more strict. Biosimilars, for example the GCSF, the granulocyte colony stimulating factors, growth factors to help to prevent myelosuppression induced by chemotherapy, GCSFs can be copied when the patent is lost, giving birth to biosimilars from competing sources and pharmas. So there is a field of GCSF growth factors, erythropoietin for anaemia and very soon, according to the timetable of losses of patent, that’s all the field of antibodies, antibodies like anti-angiogenic agents like bevacizumab, like anti-HER2 therapy, like trastuzumab, all these drugs which are part of the development of innovation with personalised treatment. So it’s a very, very important field in the future, in the near future because the first one to lose its patent is Herceptin and it is a paradigm of personalised treatment in cancer today. From 2014, I think, some biosimilars will be available to challenge the initial compound.
Does this mean the price of drugs could come down?
Certainly because we have the mirror of what happened with generics for chemical synthesis with drugs and that impacted greatly on the market allowing more expression of more competition and bargaining and the decrease of some cost. So it should happen for these innovative products the same and maybe it will expand more swiftly because the stakes, the challenge, is even greater in terms of a symbol of personalised treatment with antibodies for specific targets which is really one of our daily dreams as oncologists. So I suppose that things will move quite swiftly and we have the same for anti-angiogenic agent, anti-EGFR, as well.
How soon could a biosimilar be approved for use once a patent expires?
It’s still a bit hazy in my mind. What I mean is that the rules, the requests from the regulatory authorities may move also, they will need to provide data on pharmacokinetics, on activity at the preclinical level but also at the clinical level so they will require almost the same type of development as the original compound with efficacy and clinical data. In oncology, since we rely very often for this type of compound on outcomes, on survival results, it can take time. So if I take the example of trastuzumab, or bevacizumab maybe soon, trials have started already, almost two or three years ago and similar moves have been started also with anti-angiogenic agents. So you can expect that it takes a minimum of four years, more or less, to get some real development for ready to use compounds.
What are the implications for geriatric oncology patients?
The issue in the geriatric oncology world is that we have the convergence of three phenomena – an aging population, an increase in incidence of cancer because of aging, partly, and an increase in cost. So all these three moves converging are going to be helped in terms of practical issues by the development of alternative compounds like biosimilars because the panel of possibilities of drugs that we will get will increase also. At the same time it will allow us to reduce the costs which is really a big problem today; we know that our health systems are out of control on many aspects and the cost of innovation remains important. We can say, however, that the cost of drugs is not the only aspect because the decrease that we can expect from such development of biosimilars is maybe between 15-20%, 25%, so it’s still a huge contribution of the organisation aspects. But what we’ll spare on drugs we’ll be able to put on other aspects as stimulating or developing geriatric collaborations between oncologists and geriatricians. That will be at stake, for me.