Current and Next-Generation Biosimilars in Oncology
The discrepancy between when the FDA approves a product vs when a product is available and insight into the next generation of biosimilars.
Bhavesh Shah, RPh, BCOP: What I can add to that is that a lot of payers actually look to NCCN [National Comprehensive Cancer Network] Guidelines for coverage. Basically, NCCN has a compendium, and if they list that drug in that compendium, that means Medicare and any payer has to cover it. So it does actually help biosimilars if they’re listed at the NCCN Guidelines for indications that are off-label.
Anthony Mato, MD, MSCE: Let’s go back to our list. What else is there?
Tim Peterson, PharmD, BCOP: We’re working on this list. They started in 2017. We have our 5 trastuzumabs, and we now have 2 rituximab biosimilars. The biggest part of this has been the supportive care proteins that we have. We can have therapeutic proteins such as the filgrastims. Filgrastim has 2 different biosimilars that are currently available. It oddly enough has another pseudogeneric that came out before the biosimilar pathway was approved, and that’s tbo-filgrastim, or Granix. That went through the original 351(a) biologic pathway. It actually doesn’t have all the indications that the other biosimilars do, but that’s another option that we have in that setting. Then for our pegfilgrastim, we also have 3 biosimilars that are available in that context too. It’s a rapidly growing area.
Marc Earl, PharmD, BCOP: The 1 piece that’s been confusing in this space is when the FDA approves a product and when a product is available. Many of these products were FDA approved a few years ago, and the product did not become available until this year. That caused a lot of confusion with our physicians, our nurses, and our pharmacists saying, “Yes, I saw this FDA approval of biosimilar. Can we use it tomorrow?” We’re then having to talk through that. It may not be available for a certain period of time, and we didn’t always know that. That caused some confusion as well about how many products we have, what we can use, and when.
Anthony Mato, MD, MSCE: What about what’s coming down the road in the near future? Does anyone have any knowledge of what’s the next generation of biosimilars or classes to come our way?
Tim Peterson, PharmD, BCOP: Now that we’re starting to open up into the oncology world, a lot of these drugs, these antibody therapies, are starting to come off patents. This area is really going to explode. I know that the next couple that I’ve seen are a couple of our EGFR [epidermal growth factor receptor] monoclonal antibodies are likely in the very near future. That would be panitumumab and cetuximab, which are probably going to be forthcoming shortly. I’ve seen that denosumab, our RANK ligand inhibitor, that can be used for either osteoporosis or prevention of skeletal-related events in prostate and breast cancer or multiple myeloma. That’s likely to be coming in the near future too. But that’s 1 that I envision having a lot of patent litigation issues because it was originally approved for a different indication. I envision that 1 taking quite a while to become commercially available, as Marc was referring to.