First biosimilar product approved by FDA could signal relief from rising drug costs is on the horizon
In March, the U.S. Food and Drug Administration (FDA) green-lighted Zarxio (filgrastim-sndz), the first biosimilar product to be approved in the United States. Produced by Sandoz, Zarxio is approved for the same indications as Amgen Inc.’s Neupogen (filgrastim).
A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-approved biological product, known as a reference product. “Approved biologic products will have minor differences in clinically inactive components from one production batch to another comparable production batch of the same drug,” explains Craig Coulter, director, Pharmacy Strategic Sourcing for HealthTrust. “This is true for all biologics; however, the biosimilar must also show it has no clinically meaningful differences in terms of safety and effectiveness from the referenced biologic product.”
The facilities that manufacture U.S.-approved biologic pharmaceuticals, including biosimilars, are regularly inspected by the FDA. They must meet stringent manufacturing practice standards to ensure ongoing product quality.
Biological products are generally derived from living organisms, including humans, animals, microorganisms and yeast. Their production is complex and expensive compared to the manufacturing of traditional generic medications. Biosimilars will introduce competition—and much-needed cost relief.
“Biosimilars will provide access to important therapies for patients who need them,” said former FDA Commissioner Margaret A. Hamburg, M.D., at the time of the approval. “Patients and the healthcare community can be confident that biosimilar products approved by the FDA meet the agency’s rigorous safety, efficacy and quality standards.” (Hamburg resigned in March, and Stephen Ostroff, M.D., took over as acting FDA commissioner.)
Though the less-expensive biosimilars have been used in Europe for years, none had been sanctioned for use in the United States until now. Part of the reason is that there wasn’t a clear approval procedure.
“That changed with the passage of the Biologics Price Competition and Innovation Act of 2009, which could mean more biosimilar approvals in the near future and a healthy reduction in healthcare costs,” Coulter adds.
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