Biosimilar drugs will carry a four-letter suffix on the nonproprietary names they share with brand-name biologic drugs, the Food and Drug Administration announced Thursday. It's a move that could determine how lower-cost alternatives compete against their original counterparts.
The Food and Drug Administration announced its plan for biosimilars, which copy a biologic drug but are not identical in their composition or production, in a blog post.
The agency's goal is to allow for easier post-market tracking of all biological products as well as to avoid a drug bring switched with another that isn't interchangeable. Pharmacists currently can switch from a branded biologic to a cheaper biosimilar without physician consent, as they do with chemical generic drugs.
“Our current thinking is that shared non-proprietary names are not appropriate for all biological products,” the draft guidance stated. “There is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable.”
The agency's suffix proposal would work like this: the original drug might be labeled "drug-cznm" and a biosimilar version could be labeled "drug-hixf." The codes would not have any meaning.
“I think this naming convention is a look down the road to a future where biosimilars are much more common and prescribing becomes much more complex,” said Andrew Mulcahy, policy researcher at the RAND Corporation.
The FDA is seeking comment on whether to designate the same name to biological products that are approved to be interchangeable.
Some estimate the biosimilars U.S. market 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.
Next week, Novartis is scheduled to launch its biosimilar version of Neupogen, a blockbuster Amgen drug used to boost blood cells in certain cancer patients.
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, urging the FDA to designate such drugs with the same nonproprietary name as the original biologic.
Experts predict the way biosimilar products are labeled would be key in determining the success of the biosimilars industry, which is seen as important to the future of controlling rising drug costs.
