The presentation at the National Comprehensive Cancer Network reviewed regulatory requirements and updates in the 2019 guidelines that affected biosimilars.
Acceptance of biosimilars in cancer care will require oncologists to demand just the right amount of data on these products, according to Gary Lyman, MD, MPH, of the Fred Hutchinson Cancer Research Center and the Seattle Cancer Care Alliance.
In a presentation last week during the annual conference of the National Comprehensive Care Network (NCCN), Lyman said oncologists need enough data to feel comfortable that biosimilars work as well as their reference products, but they cannot expect so much that the cost savings are wiped out.
“This would defeat one of the primary purposes of their development,” he explained. “But if we don’t require enough [data], while making the approval process easier—prices will come down—it will lower our confidence that adequate due diligence has been done.”
Finding that sweet spot remains a work in progress in the United States, where biosimilars have struggled, Lyman said. He encouraged the oncologists at the NCCN conference to look to the European experience as a guide. He noted that more than 25 biosimilars have been approved in the European Union since 2006, but that the monitoring system had not identified “any relevant difference in the nature, severity, or frequency of adverse effects between biosimilar medicines and their reference medicines” in 10 years.
Both the FDA and the European Medicines Agency require ongoing monitoring of the manufacturing processes for all biologics, which Lyman said is essential to ensure quality and safety.
Biosimilars as a Means to Improve Access
Much of Lyman’s presentation was aimed at giving those unfamiliar with biosimilars an overview of why these biologics can offer a way to ensure patient access to innovative biologics, including those developed for cancer treatment. He presented data from IMS Health that show global spending on biologics continues to outpace that of spending on pharmaceuticals overall, reaching $221 billion in 2017.
He reviewed FDA evidence requirements for biosimilars as well as the March 2015 approval of the first US biosimilar, filgrastim, sold as Zarxio, a granulocyte colony-colony stimulating factor (G-CSF). Filgrastim biosimilars that reference the originator product, Neupogen, remain among the most common worldwide, although Lyman noted that there are other FDA-approved biosimilars of interest to the oncologist; 1 each for rituximab and bevacizumab, and 4 different ones that reference trastuzumab.
He pointed to updated areas of the 2019 NCCN guidelines, using prostate cancer as an example, and showed where different G-CSF products are listed for treatment of neutropenia: the prostate cancer guideline included 2 biosimilar versions of G-CSF, Zarxio and Nivestym, as well as tbo-filgrastim (Granix), which was approved before the biosimilar pathway existed. It also included 2 products that reference pegfilgrastim, Fulphila and Udenyca.
Lyman also took note of the 2018 FDA approval for Retacrit, which references epoetin alfa, a medication that stimulates erythropoiesis and is used to treat anemia that occurs in chronic kidney disease associated with chemotherapy. The NCCN update in prostate cancer states, “The panel extrapolates that there would be no clinically meaningful difference for treatment of [chemotherapy induced anemia].”
Transparency Is Key
Lyman explained that physicians remain skeptical about biosimilars and fear that payers or health systems will force their use for cost reasons. The availability of strong clinical data will be essential to ensure that clinicians accept biosimilars, he said.
“NCCN is very concerned that we have access to the data that the FDA have,” he said. Whether the guidelines committees get the data from FDA or directly from the manufactures, Lyman said, it is essential to have this information so that biosimilars can be integrated into the guidelines going forward.
The naming convention is extremely important, so that if there are adverse effects, providers know which biosimilar was used. “If we don’t know or if our patients don’t know what form of trastuzumab was used, that’s an injustice to our patients,” he said.
He pointed to a May 2018 policy statement from the American Society of Clinical Oncology, for which he served as lead author, which discussed naming and regulatory considerations, safety and efficacy, interchangeability, switching, and substitution; the value of biosimilars, and provider and patient education.1
There’s no question, Lyman said, that “biosimilars will be playing an important role.”
Lyman GH, Balaban E, Diaz M, et al. American Society of Clinical Oncology statement: biosimilars in oncology. J Clin Oncol. 2018;36:1260-1265.