The American College of Rheumatology has issued a white paper supporting the use of biosimilars as treatments for rheumatic diseases.
It had urged caution when the first biosimilars for these disorders were being developed and evaluated. But mounting evidence of their success in Europe and to a lesser extent the United States prompted the organization to revise its position.
“During this period of transition, it is reassuring to recognize the scientific rigor with which the FDA [the U.S. Food and Drug Administration] and other regulatory agencies around the world have evaluated biosimilars,” the organization wrote. “Healthcare providers should now incorporate biosimilars, where appropriate, into regimens to treat patients with rheumatologic diseases.”
The white paper that researchers produced, titled “The Science Behind Biosimilars: Entering a New Era of Biologic Therapy,” appeared in the journal Arthritis & Rheumatology.
FDA officials define a biosimilar as a “biologic product that is ‘highly similar to’ an approved biologic product.” It also stipulates that there be “no clinically meaningful differences” in safety or effectiveness between a biosimilar and the therapy it is mimicking.
The FDA had approved nine biosimilars for rheumatology-related conditions as of December 2017. Six are tumor necrosis factor inhibitors for rheumatologic and other inflammatory diseases. The other three are biosimilars of the widely used juvenile arthritis medications Remicade (infliximab), Humira (adalimumab) and Enbrel (etanercept).
Approved biosimilars of Remicade include Inflectra (infliximab-dyyb), Renflexis (infliximab-abda), and Ixifi (infliximab-qbtx). Erelzi (etanercept-szzs) is an approved biosimilar of Enbrel. Cyltezo (adalimumab-adbm) and Amjevita (adalimumab-atto) are approved biosimilars of Humira.
One reason to change a patient from an approved original medicine to a biosimilar is cost savings, of course, the white paper observed.
Clinical trials covering people with rheumatoid arthritis and other inflammatory diseases have shown that biosimilars are as effective and safe as the originals, it added.
“We expect that transitioning and non-medical substitution will become as common in the U.S. as it has in Europe and the rest of the world,” the researchers wrote.
A successful transition between an original drug and a biosimilar requires communication between healthcare providers, pharmacists, and patients, the team emphasized.
“We remain optimistic that the use of biosimilars will improve patient access to biologic agents, allowing continued delivery of high-quality healthcare to be realized at a lower cost to the individual patient,” they wrote.
A Texas rheumatology expert is still urging caution, however. Dr. Roy Fleischmann wrote an editorial that accompanied the white paper titled “The American College of Rheumatology White Paper on Biosimilars — It isn’t all White — there is some gray and black.” He is with the University of Texas Southwestern Medical Center and Metroplex Clinical Research Center in Dallas.
While the white paper contends that switching from an original drug to a biosimilar will not affect a treatment’s safety or effectiveness, “these questions are still open amongst many rheumatologists,” Fleischmann wrote.
“As rheumatologists, we don’t treat groups of patients,” he said. “We treat individual patients, and here the results may be different.”
There are a number of reports of patients in Denmark, Norway and the Netherlands not doing as well on biosimilars as on the originals they were switched from, he said. In some cases, the biosimilar was ineffective. In other cases, it led to an adverse event, he said.
“A patient who responds and tolerates a bio-original who does not respond or tolerate the biosimilar of that molecule, may benefit from being retreated with the bio-original,” he added.
He also contended that scientific evidence is needed on two other questions. One is whether a biosimilar’s effectiveness translates from one disease to another. The other is whether several biosimilars of the same drug are as safe and effective as the original and each other.
Fleischmann also questioned the notion that the major cost savings from biosimilars are accruing to patients. They may instead be accruing to pharmacy benefit managers — companies that manage drug costs for many health insurers, he said. These companies decide which medications are available to a lot of American patients and at what price.
“It is not at all clear that a biosimilar will be cheaper to the patient,” Fleischmann in a news release. “It may be cheaper to the pharmacy benefit management firm, but this may not really help patient access to these medications.”
These are some of “the major questions remaining unanswered with respect to the use of biosimilars in rheumatic disease,” he added.