Why is the FDA creating unnecessary obstacles to biosimilar drugs?

The Food and Drug Administration (FDA) is getting close to approving the third and fourth biosimilar drugs under the Biologics Price Competition and Innovation Act (BPCI), which was signed into law in 2010. This is great news, as the U.S. lags behind other countries when it comes to approving and using biosimilars, which are highly similar copies of biologic drugs. Just as the Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act, helped to speed up and simplify generic drug approvals, BPCI will do the same for biologics.

{mosads}And just like generic drugs, biosimilars will provide substantial cost savings to taxpayers, third-party payers and patients. Although the approval process is proceeding forward, the FDA has issued two guidance documents, one of which would likely make it more difficult to prescribe and dispense biosimilars, while the other requires information that is unnecessary and could cause a misinterpretation about the safety of biosimilars.

In March 2015, the FDA approved the first biosimilar, Sandoz’s Zarxio. The drug is highly similar to the Amgen biologic Neupogen (filgrastim). Since the FDA had not yet released guidance on how it would designate a nonproprietary name for biosimilars, the agency gave Zarxio a placeholder name of “filgrastim-sndz.” Chemically based brand-name and generic drugs have long shared the same nonproprietary name, such as ibuprofen or acetaminophen. If the same practice had been applied to the Zarzio, its nonproprietary name would have been designated as filgrastim, the same as Neupogen.

Nonproprietary names are important in the pharmaceutical industry because they aid in precise prescribing and communication among health professionals, from researchers to physicians to pharmacists to insurance companies. They are also officially recognized by government agencies and other official organizations.

When the FDA issued Zarxio’s nonproprietary name, Citizens Against Government Waste (CAGW) — of which I am president — objected to the unnecessary suffix, and pointed out that the BPCI did not require different nonproprietary names for products approved under the abbreviated pathway to approve biosimilars. Rather than fixing this problem, the FDA’s August 2015 draft guidance, “Nonproprietary Naming of Biological Products,” made nonproprietary names even more confusing for health professionals. The guidance called for the addition of non-meaningful and distinct four-letter suffixes attached to the nonproprietary names of biosimilars and their brand-name biologics. This would result in Zarxio’s nonproprietary name changing to “filgrastim-bflm” and Amgen’s nonproprietary name changing from filgrastim to “filgrastim-jcwp.”

CAGW agreed with the Federal Trade Commission’s opinion that the final adoption of the draft guidance “could result in physicians incorrectly believing that biosimilars’ drug substances differ in clinically meaningful ways from their reference biologics’ drug substances, especially since differences in drug substance names have traditionally connoted meaningful differences in drug substances.”

In March 2016, the FDA released draft guidance, “Labeling for Biosimilar Products, Guidance for Industry.” CAGW is generally pleased with the document, including the requirement that the brand-name biologic’s clinical information on safety and efficacy, rather than data demonstrating biosimilarity, is part of the label. But then the FDA goes off the track by requiring a “biosimilarity statement.”

If the drug has been approved by the FDA, it means that there are no clinically meaningful differences between the biosimilar and the brand-name biologic in terms of safety, purity and potency. There is absolutely no need to repeat that information with a comment on the label that the new product was approved to be a biosimilar to its respective brand-name biologic. This kind of information is not required in other pharmaceutical products that have been found to be therapeutically equivalent.

Should the FDA finalize the August guidance and not remove the biosimilarity statement in the March guidance, the agency would be creating obstacles to biosimilars by both sending a signal that they are not as safe or effective as their corresponding brand-name biologics, and raising questions about the two types of drugs that are not broached with respect to brand-name chemical drugs and their generic versions.

With different nonproprietary names and superfluous information in labels, the use of biosimilars might be questioned by health professionals and patients, negating the good work that has been accomplished in trying to catch up with other countries that have been utilizing biosimilars — with the same nonproprietary names — for many years.

Schatz is president of Citizens Against Government Waste.

The views expressed by contributors are their own and not the views of The Hill.



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