Joseph Alvarnas, MD, vice president of government affairs at City of Hope and chief clinical adviser of AccessHope, explains what the recent FDA approvals of Stimufend and Vegzelma, 2 oncology biosimilars, says about the current state of the oncology biosimilar space.
Recently, the FDA approved a sixth pegfilgrastim biosimilar (Fresenius Kabi’s Stimufend) and a fourth bevacizumab biosimilar (Celltrion Healthcare’s Vegzelma), the fourth and fifth oncology biosimilars to be approved in 2022 so far. What do these approvals tell you about the current status of the oncology biosimilar space?
Alvarnas: So, the key thing about biosimilars is when the concept first came, a lot of us were thinking, "What a quaint idea." And I think there was a lot of skepticism as to whether or not this would translate into something real. I think with the new approvals, what you see is this is something real—that we have biosimilars for a significant number of meaningful oncology products.
As we see multiple biosimilars enter into a competitive race with the originator molecule, then you get to a market-competitive model that can begin to address issues of drug pricing that can foster better stewardship as well as better engagement of clinicians as they think through their purchasing contracts, their supply chains, and clinical care pathways.
So, when we look at the portfolio of all the approved biosimilars, this constitutes something real. This constitutes a path forward toward embracing deeper models of value that don't compromise patient outcomes and don't compromise patient access by ensuring that we can be both value centered and yet extraordinary stewards of great care.