“With biosimilars, we’re talking about demonstrating similarity to a reference product that [has already proved] to be safe and effective,” said Dr. Christl. “When we talk about switching drugs in the U.S., that’s interchangeability, which is [held to] a different standard. But biosimilarity is not [held to] a lesser standard of safety and efficacy. The impact of switching and alternating drugs—the data must address that.”
Distinct names will promote pharmacovigilance, making it easier to monitor, track, and report adverse events for biosimilars, Dr. Christl added. The Academy of Managed Care Pharmacists has launched a program, the Biologics and Biosimilars Collective Intelligence Consortium, to help pharmacists report and track these data.
Cost Creates Urgency
Surging costs of biologics make solving these issues a pressing matter, because many patients can’t access life-changing therapies, said Barbara Finck, MD, chief medical officer of Coherus Biosciences and a rheumatologist. Biosimilars will create competition that could save patients money while still meeting the same high standards, she said.
“Biosimilarity is really about variability. It’s about how close we can match that innovator drug. If it matches closely enough, you may not even need a clinical trial,” said Dr. Finck.
Biosimilars could cost as much as 20% less than biologics, improving patient access, said Leigh Purvis, director of health services research for AARP. Cost sharing for patients has risen dramatically, so even with insurance, they can’t afford biologics.
“We don’t think there’s anything to be afraid of,” Ms. Purvis said. “The FDA has safety and efficacy covered. We want the competition. The competition will only happen if you allow substitution.”
Work Together
The debate around biosimilars is complex, but if stakeholders work together, the obstacles can be overcome to the benefit of everyone, said Dr. Worthing.
“It’s easy to get lost in the weeds of regulatory issues, but biosimilar naming, labeling and interchangeability issues have real and profound safety and health consequences for patients,” he said. “Rheumatologists are looking forward to prescribing biosimilars.”
Susan Bernstein is a freelance medical journalist based in Atlanta.
