Adam M. Brufsky, MD, PhD
For those who might question the equivalence of biosimilars to their reference products, it is important to remember the strict guidelines in place to ensure similarity before they reach the United States market, explained Adam M. Brufsky, MD, PhD.
, Brufsky shared insight on the impact of biosimilars in the field of oncology and outlined other strategies and steps that can be taken to mitigate cost when treating patients with breast cancer.
OncLive: How will the approved trastuzumab biosimilars impact the HER2-positive landscape?
: While the trastuzumab biosimilars have been approved, they have not been marketed yet, which means that no one has actually started using them [in practice yet]. There are some biosimilars that will impact the field more quickly. For example, we have already been using the biosimilar G-CSF and there is now a pegylated biosimilar G-CSF that has been recently approved as well. Several trastuzumab biosimilars will probably receive approval in the next year or so.
This [cost reduction] is a big deal for society in general—not just in the oncology space. Everyone from our president to Congress wants to reduce drug costs. Biosimilars will go a long way, at least in the breast oncology space, particularly with the [introduction of the] trastuzumab biosimilars [into practice]. They will help reduce the cost of care by at least 15% to 20%, if not more.
What would you say to someone who is skeptical about the similarity and cost effectiveness of biosimilars?
These products have to be similar to the reference products; that is the whole idea. They must be similar in terms of biology, and there are several glycosylation assays that need to be done on the molecule to show it is almost exactly the same. The toxicity profile has to be same. Biosimilars cannot be inferior or superior; if they are, that defeats the purpose of their development and they will not be approved. There is a very specific process that the FDA has devised to determine if these drugs are the same. Therefore, to any skeptic who says that they these products are not the same: They have to be; that's number 1.
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