The ACR Is Leading the Way
Rheumatologists have made biosimilars a high legislative priority to ensure that physicians’ voices are heard. Testifying on behalf of the American College of Rheumatology at the Feb. 9 meeting, Angus B. Worthing, MD, FACR, FACP, a rheumatologist practicing in Chevy Chase, Md., expressed the need for these lower-cost treatments.
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“As more biologic drugs are used to treat rheumatic diseases, rheumatologists are increasingly concerned about their high costs and patients being able to afford them,” said Dr. Worthing, a member of the ACR Government Affairs Committee. “The ACR strongly believes that safe and effective treatment alternatives should be made available to patients at the lowest possible cost.”
CT-P13 is a biosimilar monoclonal antibody manufactured by Korea-based Celltrion. Called Remsima outside the U.S., it was approved by the European Medicines Agency (EMA) in 2013 and is also approved in Canada and Japan. Remicade, which was first approved by the FDA in 1998, is owned by Janssen Biotech Inc. and is used to treat rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.
It won’t be the first biosimilar on the U.S. market—filgrastim-sndz (Zarxio), a cancer drug approved by the FDA in March 2015, has that distinction—but it’s an important milestone on the road to more affordable rheumatologic treatments, said David Daikh, MD, PhD, Kenneth H. Fye Chair in Rheumatology at the University of California, San Francisco.
“The potential for cost savings for patients and the availability of more cost-effective, effective treatment options are the obvious, hoped-for benefit of these drugs,” said Dr. Daikh. This year, companies that make biosimilars to etanercept (Enbrel) and adalimumab (Humira) are expected to seek FDA approval.
‘As more biologic drugs are used to treat rheumatic diseases, rheumatologists are increasingly concerned about their high costs & patients being able to afford them. The ACR strongly believes that safe & effective treatment alternatives should be made available to patients at the lowest possible cost.’ —Dr. Worthing, member of the ACR Government Affairs Committee
Because they are complex molecules that depend on living cells, biosimilars aren’t as simple to manufacture as small-molecule generic drugs. They require comprehensive testing of their immunogenicity to ensure safety. Even small changes can have major biologic effects that can potentially impact efficacy or put patients at serious risk, said Dr. Daikh.
“My major concerns are that as biosimilars are developed, there is adequate study to determine how closely they approximate their index agent, and that they are not automatically substituted as ‘generics’ because of cost or formulary preference,” he said. Rheumatologists need assurance that biosimilar use will be specifically tracked so that problems that might only turn up late and after more extensive experience can be identified, just as is done for conventionally approved unique drugs.