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

Lee Schwartzberg, MD, FACP, medical director and senior partner at The West Clinic, explains what he sees as the main challenges with incorporating biosimilars in the cancer clinic.


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.