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Here's the latest on the second biosimilar in line to receive FDA approval.
While an FDA panel recently decided that Celltrion's biosimilar, Remsima (infliximab), is “highly similar” to the branded monoclonal antibody, Remicade (infliximab), in its effect on a variety of autoimmune diseases, it is unclear when Remsima will be available or what the cost will be.
Still, the impending final approval of Remsima by FDA is just one signal that biosimilars will be big business in the United States soon. Some industry sources estimate that biosimilars could provide as much as $250 billion in savings over the next decade, while the Congressional Budget Office estimates a 10-year savings of around $25 billion.
However, a report from American Action Forum (AAF) provided a much lower savings estimate for biosimilars, hypothesizing a figure between $5.1 billion and $37.8 billion on drug expenditures from 2015 through 2024.
The AAF’s savings estimate may be lower because the organization takes into account whether physicians and pharmacists will actually recommend biosimilars to patients - along with the discounts that manufacturers of biosimilars may be able to offer.
“Unlike traditional generic drugs, it is expected that the relatively low discounts and high-investment cost expected with biosimilars will create competition between biosimilars and brand-name biologic drugs that is more similar to competition between brands than between a brand and a generic,” wrote Conor Ryan, author of the AAF report and an outside health expert for the AAF.
Experts estimate that Remsima, which is already available in many European countries, will be priced around 25% lower than Remicade in the United States.
Vibeke StrandHowever, the price for the biosimilar infliximab is not yet determined, so “it is not appropriate for us to assume the size of cost savings to consumers and the U.S. healthcare system,” Alex Kudrin, MD, PhD, and and Vibeke Strand, MD, told Drug Topics via e-mail. Kudrin is vice president of clinical development for Celltrion and Strand is an adjunct clinical professor in the Division of Immunology/Rheumatology, Stanford University School of Medicine.
The price of the biosimilar drug varies among countries, since it is set according to the local regulations and pricing systems.
“Celltrion, as a biosimilar developer, is committed to delivering high-quality, affordable medications. We hope that biosimilars’ price is determined in a way that it contributes to larger cost-savings and better treatment opportunities granted to patients,” Kudrin and Strand said.
It is too early to speculate on when the drug will launch, since Pfizer will handle the release, they added. Pfizer assumes the U.S. commercialization rights for the biosimilar monoclonal antibody and plans to market the drug under the brand name Inflectra.
FDA scientists released a favorable report on Remsima before the February 9 meeting of an independent medical advisory panel to the agency. In a vote of 21-3, the U.S. FDA Arthritis Advisory Committee recommended approval of all indications for the biosimilar monoclonal antibody, including moderately-to-severely-active Crohn's disease, ulcerative colitis, and rheumatoid arthritis, as well as active ankylosing spondylitis, active psoriatic arthritis, and chronic severe plaque psoriasis.
“The diseases for which Remicade is indicated for are serious, chronic diseases that have a significant negative impact on the quality of life for patients,” Kudrin and Strand said. “Once alternative, lower-cost treatment options like biosimilars become available, patients in the U.S. will have increased access to biologics to treat their diseases more effectively and timely.”
Remsima would become the second biosimilar approved by FDA. Novartis debuted Zarxio (filgrastim-sndz), a biosimilar of Amgen’s Neupogen (filgrastim), last September.