Biosimilar Adoption by Scientific Evidence

Dr. Brian Bressler, MD, MPh, FRCPC, Gastroenterologist

Duration: 2 minutes, 46 seconds

Ever since biosimilars have entered the market in Canada, we have been interested, and in some respect critical of the way health authorities have approached this particular idea. And what I mean by that is that the health authority, rightfully – in their own right – took a very different approach to saying that a particular molecule has the similarity as the innovator.

We are used to looking at clinical studies and evaluating a potential new opportunity for a patient in a clinical context. That’s not what the health authorities did, and to their credit, they took the right approach. In particular, what I’m referring to, is they focused on the qualities in the molecule, the pharmacodynamics, the pharmacokinetics of the molecule.

And with those evaluations, they deemed whether a biosimilar truly was as similar as it needed to be, with an innovator molecule. But when that first started as bodies, as governing bodies of certain specialities, we were hesitant to really endorse that idea. And we wanted our own studies in our own patient groups to really understand whether this molecule can be used for our patients.

So over time we’ve learned that they were probably more right than we were, and this idea of extrapolations, the idea of using a biosimilar in indications that weren’t specifically studied in a clinical context, seems to be valid, based on the continuing strength of evidence that is coming to bear.

When having a discussion to patients with regards to using a biosimilar compared to an innovator molecule, in many regards that’s a tricky discussion. And the points that I would focus on is how science has enabled us to have the opportunities to use a molecule that could lead to the potential similar efficacy and similar safety of a molecule that we have been so comfortable with for many years, in that particular patient.

I would reinforce to a patient, when discussing to patients, that indeed these molecules have been studied in ways that the health authorities in our country, so in Canada Health Canada, has deemed to be appropriate. And we’re following very carefully, and very closely, the guidance of Health Canada when making these decisions with regards to the potential value of using a biosimilar instead of the innovator molecule.

Presenter: Dr. Brian Bressler, Gastroenterologist, Vancouver, BC

Local Practitioners: Gastroenterologist