The biosimilars market began to pick up in 2017 as federal agencies offered more clarity about the emerging regulatory landscape and the FDA issued draft guidance on naming and interchangeability. Those regulatory clarifications will help bring the United States into the biosimilars era—if their manufacturers can seize sufficient market share, according to experts.
Until November 2017, Medicare Part B payment policy for biosimilars left manufacturers unclear as to how they would compete with reference biologics, says Amanda Forys, MSPH, Senior Director at Xcenda, a part of AmerisourceBergen.
CMS had indicated in 2016 that biosimilar products for a given reference biologic would all share a single billing code separate from the reference product, meaning that Medicare Part B would reimburse each biosimilar at the same rate—the average sales price for all products sharing that billing code plus 6% of the reference product’s average sales price, Forys says.
That would have been caused uncertainty in biosimilar pricing for providers compared to reference products and could have created challenges for pharmacovigilance, as biosimilars are not interchangeable with one another. Together, these challenges could have significantly slowed provider uptake of biosimilars, she says.
But in November 2017, the CMS issued final rules for the Physician Fee Schedule and the Hospital Outpatient Prospective Payment System that instead establish unique billing codes for each biosimilar. The rules will take effect in 2018.
That decision will encourage competition in the biosimilars market and ultimately hasten patient access to less-expensive drugs, Forys says. “Where we still have a problem and need to think about the next step is Medicare Part D. Biosimilars do not count as branded products under the Medicare Part D program, which means manufacturers cannot participate in the coverage gap discount program, which provides patients discounts in the ‘donut hole’ [coverage gap].”
The FDA also released in 2017 draft guidance for establishing interchangeability, says Gary H. Lyman, MD, MPH, codirector of the Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, and professor of medicine at the University of Washington School of Medicine, in Seattle.
To be deemed interchangeable with their reference biologics, biosimilars will have to meet additional regulatory requirements, including evidence that the product is expected to produce the same clinical results as the reference product and that the safety and efficacy effects of switching between reference biologics and the biosimilar product has been evaluated.
No biosimilars have yet been approved as interchangeable and that’s unlikely to change in 2018, Lyman suspects. But state governments will become bigger players in implementing biosimilar interchangeability, as more state legislatures weigh in on implementation of interchangeability for biosimilars prescribing.
“Thirty-five states already—and more to come—have preempted forthcoming federal rules on interchangeability, switching and notification,” Lyman says.
‘Landmark year’ for oncology biosimilars
Biosimilars began to move into clinical oncology in 2017, with the FDA’s first approval of an anticancer biosimilar for Avastin (bevacizumab). Mvasi (bevacizumab-awwb), is approved for treating metastatic colorectal and renal cell carcinoma, cervical cancer, glioblastoma, and non-squamous non-small-cell lung cancer, and will likely be available in 2018, says Lyman.
In May 2017, the FDA Oncologic Drugs Advisory Committee also recommended approval of an epoetin alfa biosimilar across all indications of reference biologics for treatment of anemia. Lyman says this will likely gain approval in 2018 or early 2019.
The FDA also approved biosimilars in 2017 for the tumor necrosis factor-alpha (TNF-α) inhibitors Renflexis (infliximab) and Cyltelzo (adalimumab) for Crohn’s disease, ulcerative colitis, rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis, Lyman says. The Cyltelzo biosimilar, Adalimumab-adbm, was also approved for juvenile idiopathic arthritis. The Renflexis biosimilar (infliximab-dyyb) was introduced in October 2016.
2018 will be another landmark year for oncology biosimilars, Lyman says. Biosimilar trastuzumab, rituximab, cetuximab, and other versions of bevacizumab are likely to gain approval in 2018 or early 2019.
“For the first time we will have biosimilar anticancer drugs and not just biosimilar supportive care agents like filgrastim,” he says.
“Patients who are currently doing well on an originator biologic are likely to continue on that per patient and provider preference,” he says. “However, changes may be forced based on reimbursement or formulary restrictions even in the absence of an interchangeable label.”