The value and strategy for incorporating biosimilars Into clinical practice
Dr Francisco Esteva - New York University, New York, USA
My educational session is about biosimilars in oncology, so we have three speakers, one from the FDA, one from the EMA, which is the European agency, and then myself will try to put this in perspective and discuss what are the clinical applications as well as the challenges that we will face as some of these biosimilars will be hopefully approved by the FDA.
Just a little background – what is a biosimilar?
Biosimilars are protein-based therapeutics that are made in live cells, as opposed to generics which are basically chemicals. They are not identical to the original or the originator drug because it’s basically impossible to make the same protein being identical in two different cell lines. But they are similar enough that their structure is almost the same, their function is the same. Then on top of that they have to show that in clinical trials the pharmacokinetics are the same as the originator and the safety and efficacy are also pretty similar.
When it comes to the clinical application what would be talked about at the session in terms of bring these to clinics?
None of the therapeutic biosimilars are approved in the US yet; once they are approved we will have to educate oncologists and patients to make sure they understand that these are basically the same type of treatments and that is one of the challenges because, as opposed to supportive care, biosimilars like GCSF which was approved by the FDA last year, when we are talking about therapeutics for cancer there may be more anxiety about substituting or using a biosimilar as opposed to the originator drug even though they’re the same. So at the ASCO meeting this year Dr Hope Rugo presented this randomised phase III trial, for example, where one of the trastuzumab biosimilars had the same, even better, efficacy than Herceptin and similar toxicity side effect profile. So that, in my opinion, would make it acceptable should the FDA approve it for use.
It sounds like all of this is still very much yet to be developed, yet to be discovered, but with things as they are now, apart from the regulation aspect of things, can you see any limits to biosimilar therapy?
There is no limit in terms of the application of this type of technology because once a patent expires anybody can make a biosimilar if you have the right technology and knowledge and know-how so very large companies are getting into this business, such as Pfizer, Amgen, Celltrion, all these large companies in the US. So as long as the technology is there and they know how to do it there should be technically no limit to the use of these biosimilars. There are many issues, about substitution for example - can a pharmacist now substitute a biosimilar as opposed to an original drug like Herceptin, for example. All of those things have to be resolved once they are approved. But my understanding, based on the FDA approval, if one of those agents is approved, is that still will have to be done by the oncologist or the physician so they cannot be substituted as they are, for example, with generics all the time. So these are some of the practical things we need to resolve. The other important thing in the US specifically is that patients like to take an active part in their care and they may or may not accept this type of therapeutic. So it’s very important to communicate what it means, what is a biosimilar, the fact that the results are basically identical and have to feel comfortable, both the physicians and the patients, to use one of those as opposed to the original, let’s say Herceptin, Avastin, Rituxan and so on.