Currently Available Biosimilars in the US

How biologics have changed clinical practice over conventional chemotherapies and currently available biosimilars in the US.

Anthony Mato, MD, MSCE: Any comment on biologics in general and how you’ve observed or how they’ve changed practice?

Tim Peterson, PharmD, BCOP: Clearly, we know that the development of biologics specifically in hematology oncology—lymphoma, leukemia, multiple myeloma with daratumumab, and our CD20-targeted agents for lymphoma—have made a vast difference for patients’ lives. Progression-free survival and overall survival are significantly improved. We know that biologics are a significant game changer over previous conventional chemotherapy agents that we’ve been using. Toxicity profiles can be significantly better for these agents when compared with conventional chemotherapies. But we’re now seeing this shift in the paradigm to biosimilars becoming available in different settings, and we’ll start to see more how those are adopted in clinical practice.

Anthony Mato, MD, MSCE: Thanks for giving the overview of the perspective of how these agents have impacted on cancer care in general, in terms of biologics. But certainly not all biologics are available or have a biosimilar version available of them. Do you want to touch on what we have available to us in the United States in the context of biosimilars at this time?

Tim Peterson, PharmD, BCOP: Sure. Bhavesh touched on the fact that Europe has a significant head start on us. Their first biosimilar was in 2006, whereas we had our first biosimilar approved in 2015 with the very first filgrastim biosimilar. In the oncology-specific world, 2017 was really our introduction to the biosimilar world for monoclonal antibodies with the first bevacizumab biosimilar.

Anthony Mato, MD, MSCE: Just remind us indications for bevacizumab.

Tim Peterson, PharmD, BCOP: Bevacizumab can be used for gastrointestinal cancers and colorectal cancer. What’s going to be very important in the actual adoption in clinical practice is that it has made its way into the ovarian cancer NCCN [National Comprehensive Cancer Network] Guidelines. When we’re looking at when physicians are actually going to incorporate these agents, it was given the designation that it can be a therapeutic substitution in the NCCN Guidelines for ovarian cancer. I think that’s going to specifically drive how these are incorporated into practice. So we have bevacizumab. Now we have 2 different formulations, I believe, of biosimilars for bevacizumab. For trastuzumab, we actually have 5 FDA-approved biosimilars. Not all of them are currently commercially available. That’s largely because of different patent litigations that are going on between the originator manufacturer and the biosimilar.

Anthony Mato, MD, MSCE: Remind us again the indication.

Tim Peterson, PharmD, BCOP: The indication of trastuzumab?

Anthony Mato, MD, MSCE: Yes.

Tim Peterson, PharmD, BCOP: Trastuzumab is a HER2-targeted monoclonal antibody, and that would be primarily in the context of breast cancer that’s HER2 positive, but you can also see it in gastrointestinal cancers that are HER2 positive as well. Actually, I believe there’s 1 trastuzumab biosimilar due to become commercially available soon, so that would be the fifth one that is available now.

Anthony Mato, MD, MSCE: You raised a good question that I have. If it’s not part of the originator’s label but it is part of guidelines such as the NCCN’s, what are your thoughts on being able to use the drug for that particular situation?

Tim Peterson, PharmD, BCOP: This is where it’s going to get very interesting from a payer’s standpoint. This is largely going to fall on the payers to make this decision for us.

Anthony Mato, MD, MSCE: And if anybody else has any perspective there.

Tim Peterson, PharmD, BCOP: It’s both fortunate and unfortunate in that setting because we know that they’re going to be driving some of these decisions. But we’ve also come to accept that we know these biosimilars are highly similar to the reference product, so we feel comfortable in their use. The NCCN Guidelines, as you know, it’s an expert consensus panel that if they feel comfortable giving these biosimilar agents in what is an off-label indication, that means that they’ve largely accepted likely the same scenarios that the FDA would require for a manufacturer for extrapolation of indications. They accept that the mechanism of action should be the same or similar and that the pharmacodynamics and pharmacokinetics in that patient population should be similar and expected. The NCCN can be a supplement to what the FDA has already done, but I think that’s largely going to be payer driven. It’s going to make things very complicated from a P&T [pharmacy and therapeutics] and formulary standpoint.