Fate of cost-saving biosimilar drugs may hinge on naming policy

What's in a name?

A lot, according to groups battling over whether biosimilar pharmaceutical products should be allowed to use the same nonproprietary name as branded products.

In March, in its first approval of a biosimilar product, the Food and Drug Administration designated the Sandoz product Zarxio with the placeholder nonproprietary name “filgrastim-sndz.” That was a compromise from labeling it simply as filgrastim, the nonproprietary name for the brand-name product, Neupogen, for which it is considered a biosimilar.

The FDA said filgrastim-sndz was a temporary placeholder name and should not be viewed “as reflective of the agency's decision on a comprehensive naming policy for biosimilar and other biological products.”

Experts estimated that Zarxio could be sold at a discount of up to 35% of the price of Neupogen, a blockbuster cancer biologic produced by Amgen, which can cost about $3,000 for 10 injection treatments.

The FDA naming designation for Zarxio follows the model proposed last July by the World Health Organization, which oversees the International Non-Proprietary Names system (INN). The WHO recommended that biosimilars receive the same nonproprietary name but with a four-letter code at the end.

But that compromise did not satisfy those who want to see biosimilars designated with the same INN as the biologic products whose functions they replicate. It's also opposed by those who argue that similar labeling poses patient-safety risks. The latter group, which includes brand-name drugmakers and some physician groups, says giving biosimilars the same INN designation as the branded biologic products could lead to confusion among physicians and patients over which drugs they can trust to be safe and effective. They also say using the same name could make it harder to track adverse reactions.

“A biosimilar will not have the same structure, and there can be a lot of things that happen during the manufacturing process that will lead to a drug that is similar but not the same as the initial drug,” said Dr. Kent K. Huston, a rheumatologist at the Center for Rheumatic Disease in Kansas City, Mo., speaking on behalf of the American College of Rheumatology. (In 2014, Huston received payments from Amgen and other manufacturers totaling about $446.62, according to the CMS' Open Payments website).

Some experts predict that how biosimilar products are labeled will be a key factor determining the success of the biosimilars industry, which is seen as important to the future of controlling rising drug costs. The naming issue will be particularly important when some biosimilar products eventually receive FDA approval for interchangeability, meaning that pharmacists can switch from a branded biologic to a cheaper biosimilar without physician consent, as they do with chemical generic drugs.

“In the near term, the first-order obstacles (for the biosimilars industry) are the lack of interchangeability and the prevention of automatic substitution,” said Andy Pasternak, a partner and healthcare analyst at Bain & Co. in Chicago, a management consulting firm. “Once products overcome those, the naming issue becomes more significant."

The FDA is scheduled to issue guidance this year addressing the labeling issue. None of the experts interviewed for this article were willing to predict what the agency's position will be.

A biosimilar is a product that copies an original biologic drug but is not identical in its composition or in the way in which it's manufactured. That's different from chemical generic drugs.

Some estimates have projected the biosimilars market in the U.S. will grow to $60 billion by 2020 as the patent protections on a number of biologic medications are set to expire over the next several years.

Last December, Express Scripts released a report estimating approval of Zarxio could save patients more than $5 billion in drug costs over the next decade. The report estimated that as much as $250 billion could be saved over the next decade if biosimilars being developed are approved for 11 biologic drugs that are slated to lose patent protection in the coming years.

Many see the growth of biosimilars as a way to introduce competition to a market that's been dominated for years by a relatively small number of biologics manufacturers such as Amgen and Genentech. Biologic products are among the most expensive prescription medications, with some costing more than $100,000 for a year's worth of treatment.

The potential cost savings associated with biosimilar products have led insurers, patient advocacy groups, pharmacy benefit managers and generic-drug makers to rally in support of biosimilars. They've urged the FDA to designate such drugs with the same nonproprietary name as the original biologic.

But a major safety concern voiced by skeptics of biosimilars involves immunogenicity, or the way in which a drug provokes an immune response in the body. Unlike generic drugs, biosimilars are not exact replicas of the branded biologic. They work in the same biological manner but are not derived from the same living materials and are not produced in the same way.

Huston said giving biosimilars a different name would allow investigators to determine what types of adverse reactions occur with the long-term use of a biosimilar compared with use of the original biologic product. “The immunogenicity risk of a biosimilar could be completely different than the original product,” he said.

Those who favor applying the same INN to both biologic and biosimilars say current methods for tracking adverse reactions to drugs—which include the use of the National Drug Code identification system, plus the name of the brand and manufacturer —are adequate to address safety concerns.

Ralph Neas, president of the Generic Pharmaceutical Association, said brand-name drugmakers “continue to do everything possible to try to erect barriers and hurdles to make it more difficult for patients and consumers to have access to affordable medicines in biosimilars.”

His group recently sent a letter to the FDA calling for biologics and biosimilars to share the same name “in order to ensure patient safety and avoid confusion among providers and dispensers.” It was signed by 19 other organizations, including pharmacy benefits managers CVS Health and Express Scripts, the Healthcare Supply Chain Association, public sector labor unions and health insurance groups.

Developers of biosimilar products such as Sandoz have been mired in legal battles for the past several years with manufacturers of branded biologic products that seek to block or delay the introduction of biosimilars. In addition to the lawsuits, biosimilars also face regulatory challenges that could slow their growth, Bain analyst Pasternak said. A key issue is interchangeability.

The FDA has two pathways for licensing of biosimilars. One leads to being designated as “similar” in efficacy and safety to an original biologic. The other pathway is to be approved as being “interchangeable,” which requires a much higher review standard and could take years and million of dollars to obtain the needed clinical trial data. None of the biosimilar products currently under FDA review are in the interchangeable pathway.

Correction, July 13, 2015:

Dr. Kent K. Huston received $446.62 in payments from medical manufacturers in 2014, according to the CMS' Open Payments website. An earlier version of this story had an incorrect figure.