Adam M. Brufsky, MD, PhD
There are many misconceptions about biosimilars in oncology, which may be attributed to a lack of information and education, explained Adam M. Brufsky, MD, PhD.
In 2015, the FDA approved the first biosimilar, filgrastim-sndz (Zarxio) for all 5 indications of reference filgrastim. Several biosimilars have since been approved. In September 2017, the FDA approved ABP-215 (bevacizumab-awwb; Mvasi), a biosimilar for bevacizumab (Avastin) for adult patients with colorectal, lung, brain, kidney, and cervical cancers.
Shortly after, MYL-1401O (Ogivri; trastuzumab-dkst) was approved as a biosimilar for trastuzumab (Herceptin) with indications in HER2-positive patients with breast cancer or metastatic gastric/gastroesophageal junction adenocarcinoma in December 2017.
As more of these agents come to market, Brufsky explained that the conversation on biosimilars will take precedence as cancer care becomes increasingly interdependent on the costs of therapy.
In an interview with OncLive
, Brufsky, professor of medicine, associate chief, Division of Hematology/Oncology, co-director, Comprehensive Breast Cancer Center, associate director, Clinical Investigation, University of Pittsburgh, discussed the differences between biosimilars and biologics, incentives for biosimilar use, and investigational agents on the horizon.
OncLive: How have you seen the conversation around biosimilars evolve?
: It's hard to know, but it's interesting. People are getting more used to them. The conversation is still the way it was a couple years ago. I don't think people really understand exactly what a biosimilar is. It truly has to be similar by very specific FDA criteria; it can't be superior. It has to be the same. That's a conversation we're starting to have more as some of these more sophisticated biosimilars in oncology, such as those for trastuzumab or rituximab come to market. Right now, we have a biosimilar for the G-CSF analog filgrastim-sndz. Fairly soon, we're going to have a biosimilar for pegylated G-CSF, so the conversation is going to get a little more intense as time goes on.
Who needs to address those misconceptions? Is it oncologists themselves?
It can come from pharmaceutical companies, but it really should be coming from oncologists and thought leaders. The people who understand and have experience with getting biosimilars developed and approved are the kind of people who should be doing a lot of this education.
What are the main misconceptions that people have about biosimilars?
The misconception is that they somehow could be superior. Why aren't they superior when you compare them? Why should I use this drug [if it's not superior?] The thing that has to be overcome is that it's not supposed to be superior. If in fact it is superior, it has to go through a different pathway to be approved. That is something that's not as much of a misconception as it is a concept that people need to understand. That is probably the biggest misconception.