Sunil Verma, MD
ABP-215 (bevacizumab-awwb; Mvasi), a biosimilar for bevacizumab (Avastin), was approved by the FDA In September 2017 for the treatment of adult patients with colorectal, lung, brain, kidney, and cervical cancers. This was the first approval of a biosimilar in the United States for the treatment of patients with cancer.
ABP-215 was followed by the approval of MYL-1401O (Ogivri; trastuzumab-dkst), a biosimilar for trastuzumab (Herceptin), in December 2017.
MYL-1401O is approved for the treatment of HER2-positive patients with breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma. It is currently approved for the same indications as trastuzumab; however, Genentech, the manufacturer of trastuzumab, holds an exclusive license for the metastatic gastric cancer indication. Therefore, the companies cannot market MYL-1401O for that purpose until the exclusive license expires.
In September 2017, the FDA accepted a biologics license application for the rituximab biosimilar Rixathon (GP2013), which is manufactured by Sandoz (Novartis). If approved, this biosimilar would be indicated for follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.
Although biosimilars are just emerging in the United States, the European Medicines Agency (EMA) has been recommending and approving biosimilars for more than a decade. Biosimilars for rituximab, trastuzumab, and bevacizumab are currently approved for use in the European Union.
In an interview with OncLive
, Sunil Verma, MD, professor and head of the Department of Oncology at the University of Calgary, medical director of the Tom Baker Cancer Centre, shared his insight on the approval of MYL-1401O, as well as his excitement for the future development of biosimilars across oncology.
OncLive: Can you discuss the background of the recently FDA-approved trastuzumab biosimilar?
: We are in a very interesting framework in breast cancer and in oncology at large. We must ensure that we are able to provide effective therapies, but the costs associated with these treatments are substantial. In order for us to incorporate innovation and new therapies, we need to make sure that we also transition some of our old biologics and incorporate biosimilars.
The European bodies have done this tremendously well since 2006 through the EMA’s recommendations and European Union approvals for biosimilars. In many ways, the FDA and Health Canada are now looking at this through the same lens, just at a later date. We need biosimilars to drive down the cost of biologics, and in breast cancer, trastuzumab is one of our key costs associated with treatment for breast cancer. Hence, there is a reason to look at biosimilars for trastuzumab.
It is very important to acknowledge that biosimilars are not generics. These are biological entities that require a very complex mechanism of manufacturing, and a very complex framework for us to assess whether they truly are "biosimilar" or similar in biological principles. Our healthcare regulatory bodies have a different assessment looking at different quality attributes, in order to assess whether there is biosimilarity from a manufacturing or product perspective.
From a clinical and research perspective, the endpoints when we evaluate biosimilars are different than when we evaluate novel agents. When evaluating biosimilars, there is an interest to look at different endpoints, such as response rate in the metastatic setting and pathologic complete response (pCR) in the neoadjuvant setting.
There are at least 7 new biosimilars that are currently being investigated. In Europe, there was a recent approval of a biosimilar from Samsung Bioepis based on a neoadjuvant study. The FDA recently approved a biosimilar from Mylan based on the HERiTAge study that was presented by Hope S. Rugo, MD, of the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, a few years ago. I was the discussant for that trial.