Lee Schwartzberg, MD, FACP: Challenges With Incorporating Biosimilars in the Clinic

Transcript

The biggest challenge with biosimilars now is that they're new. The regulatory process to get a biosimilar approved by the FDA is very different than the originator product, and so I think physicians have to get more comfortable with understanding how it was done.

The big difference is that they don't require a lot of large-scale phase 3 trials on the clinical level. It's really about showing that the molecule is is highly similar to the originator molecule, which of course, being biologicals, every batch is a little different anyway. Even in the originator molecule you see the same thing with biosimilars.

So the FDA concentrates on a host of technical factors to show that they're very similar and less on the clinical side. We might not have a clinical trial with a biosimilar for every single indication that the originator has, but the label will show the same indications. In fact, the labels come from the original, largely, so I think oncologists have to get comfortable with the idea that these drugs are really can be substituted in the new patient for the originator drug at a much lower cost.

That's the real value of a biosimilar: they cost less to be developed, and therefore, on the market, they are one of many solutions to reducing the total cost of cancer care, which we need to do; it's just unsustainable.

So I think as more drugs come out, as there's more education about what a biosimilar really is and how they can be used in your clinic effectively, we’ll see oncologists will become much more comfortable with it.