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.