Ruth O’Regan, MD, discusses the excitement with biosimilars and the potential impact they could have on the US drug market.
Ruth O'Regan, MD
As biosimilars inch closer to the market, conversations around cost have taken center stage. In other markets across the world, biosimilars have reduced costs in oncology—both for payers and patients.
In the United States, breast cancer may be one of the first tumor types to have a biosimilar available on the market. Currently, there is 1 FDA-approved biosimilar for trastuzumab (Herceptin), while several are in development.
The FDA approved the trastuzumab biosimilar MYL-1401O (Ogivri; trastuzumab-dkst) in December 2017 for HER2-positive patients with breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma. Biosimilars for trastuzumab in development include ABP 980 and CT-P6.
Several supportive care biosimilars have been approved, as well, including epoetin alfa-epbx (Retacrit) as a biosimilar to epoetin alfa (Epogen/Procrit) and filgrastim-aafi (Nivestym) as a biosimilar to filgrastim (Neupogen). Epoetin alfa-epbx is approved for the treatment of anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in patients with HIV infection, while filgrastim-aafi will be used to prevent and treat adverse events associated with cancer treatment, including febrile neutropenia and severe neutropenia.
Additionally, the bevacizumab (Avastin) biosimilar ABP-215 (bevacizumab-awwb; Mvasi) was approved in September 2017 for the treatment of adult patients with colorectal, lung, brain, kidney, and cervical cancers. Most recently, the FDA’s Oncologic Drugs Advisory Committee voted 16-0 recommending approval of the rituximab (Rituxan) biosimilar CT-P10 for 3 of the agent’s non-Hodgkin lymphoma indications.
In an interview with OncLive, Ruth O’Regan, MD, professor of medicine at University of Wisconsin School of Medicine and Carbone Cancer Center, discussed the excitement with biosimilars, and the potential impact they could have on the US drug market.O’Regan: Biosimilars really are beginning to take off in oncology. For breast cancer, we have seen data on trastuzumab biosimilars. We have randomized studies where they have been compared with trastuzumab, showing similar safety and immunogenicity. They are pretty much ready for primetime. It is going to be interesting because the data suggest that they are identical, but whether patients who have been on trastuzumab for metastatic disease for years will be accepting of this change—we don't know at this time.
Biosimilars are an exciting breakthrough. There are biosimilars for some of the supportive agents that we use. Therefore, this is real and it will definitely start impacting our care. This is with the hope that we can decrease the cost of drugs and what the patient has to pay.
Other things [to consider] are modes for administration. There is a subcutaneous form of trastuzumab, which is very useful outside the United States, but we don't have it yet.For biosimilars, we need to get them out there at continuing medical education meetings and national conferences so people know about them. Really, talking to pharmacists, institutions, and nurses to make sure they know about it would be the key thing.
At the University of Wisconsin School of Medicine and Carbone Cancer Center, we look at the formulary and whether there is a cheaper option than the original drug. We would definitely consider using the biosimilar. It needs to be done at the institution level, but there also needs to be information given out at meetings.It is hard because they all show some efficacy; the question is, “How much efficacy do they show?” In certain countries, where there is universal healthcare, there are very strict criteria in terms of what they approve and what they do not approve. It is all related to survival. When drugs are approved, we need to think about who they are indicated for, and how they will be used; those are very important. If you have 3 drugs that are very similar, like the CDK4/6 inhibitors, what are the differences? Are there cross-differences that we can use to help our patients? The bottom line is that we have to try to bring the cost down at the pharmaceutical company level.
One of the issues is that [cancer] drugs are incredibly expensive to develop. That is why they are costly. The cost of these drugs is lower outside of the United States, so there are things we could do in terms of legislation to do that, as well.