What's New in the Biosimilar Labeling, Naming Landscape


A panel at the ACI 10th Summit on Biosimilars focused on the recent FDA decision around the naming of biosimilar products and what that means for the industry, as well as related issues.

A panel at the ACI 10th Summit on Biosimilars focused on the recent FDA decision around the naming of biosimilar products and what that means for the industry, as well as related issues.

From Amgen’s perspective, the conversation around naming “really comes down to what’s in the best interest of patients, what’s going to help with traceability. And we think suffixes have the potential to improve traceability. And we think there's evidence that they're already starting to do that,” said Laura Sim, JD, senior counsel for the drug maker.

She first recapped some of the controversy around the FDA’s updated draft guidance, which was released in March. The agency said that it will continue to assign suffixes to newly approved innovator biologics, biosimilars, or interchangeable biosimilars. In addition, FDA does not intend to add suffixes to the names of transition products such as insulins, and once interchangeable biosimilars become a reality, the FDA will designate a proper name comprising the core name and a suffix. Any product first approved as a biosimilar and later determined to be interchangeable with its reference will keep its original nonproprietary name, inclusive of the suffix.

Additionally, the FDA is implementing an internal procedure for FDA staff to ensure consistency and transparency in the review process for suffixes, and it is considering whether it will extend its naming convention to vaccines.

The move was supported by industry organization BIO, PhRMA, patient advocacy groups, and 24 rheumatology associations, Sim said. On the other side are the Federal Trade Commission, the Association for Accessible Medicines, America’s Health Insurance Plans, and others.

Those opposed say that the FDA’s decision not to apply suffixes retroactively implies some sort of inferior status, as well as concerns that it might complicate substitution, may be confusing, and puts the country out of step globally (for instance, Health Canada said this year it would not use suffixes as part of its biosimilar naming system).

Sim said that Amgen looked at data from both the European Union and the United States involving infliximab adverse event (AE) reports. EU data show that since 2013, after the EU adopted legislation requiring AE reporting, a range of 15% to 35% of AE reports did not identify the brand name. That suggests that reporting by brand name alone is inadequate, she said.

Looking at US data, 87% of 494 AE reports used the brand name and 13% did not. Shares of AE reports with distinguishable names aligned with the market shares of the products involved, which indicates to Amgen that suffixes work, Sim said.

“The bottom line? Amgen does not see suffixes as a hindrance to our biosimilars, we don’t see it as an advantage to our originator products, we really see it as a benefit to the entire biologics market, and again, as a component that will help create a sustainable biosimilars market,” she said.

Brian McCormick, JD, vice president and chief regulatory counsel for Teva Pharmaceuticals, discussed a topic he said does not receive enough attention—the need for an expedited pathway for postapproval labeling supplements for biosimilar products.

This is driven more by the FDA than by Congress, he said. Biosimilar labels do not include biosimilarity data; they also do not include patent listings or new codes for biosimilar products.

Biosimilar sponsors can carve out protected indications from their labeling, which means that “The complexity of innovator patent estate litigation and settlements make this a critical tool for sponsors’ ability to gain approval and launch biosimilar products,” McCormick said.

What is lacking is the ability of biosimilar sponsors to carve indications back in, he said, because this model is borrowed from the generics industry. In addition, until interchangability arrives, biosimilar sponsors are depending on innovator companies to educate physicians and providers.

The implication is that “having the fullest possible labeling becomes critical to overcome barriers, drive up market share, and drive down costs,” McCormick said.

The problem, he said, is that the FDA “has no process to do any of this” and the method it does use, assigning postapproval labeling supplements as “Supplements with Clinical Data” with a 10-month clock, is “inappropriate” and undermining biosimilar makers, he said.

McCormick noted that the FDA knows it is a problem and recalled how this past January former commissioner Scott Gottlieb, MD, said that policy would be forthcoming in 2019 to allow indications to be carved back into indications without replicating clinical studies.

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