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FDA Lays Out Naming Rules for Lower-Cost Biotech Drugs

Draft guidance to be published August 28

The FDA has proposed that cheaper versions of biotechnology drugs will be distinguished from the brand-name medications that they imitate by attaching a suffix to their generic names, according to a report posted on the BloombergBusiness website.

Brand-name biologics, which are made from living organisms instead of chemicals like traditional drugs, would also carry a suffix, the FDA said in a blog post. The agency is seeking public comment on the proposal before it issues final guidance.

The FDA said its proposal would help prevent doctors and pharmacists from inadvertently substituting one drug for another when the agency has determined the drugs aren’t interchangeable. It would also make it easier to track the safety of each manufacturer’s drugs, the agency said.

The FDA also said it hasn’t decided whether biosimilars that are considered interchangeable –– which means they can be substituted for a brand-name version at the pharmacy counter –– would require a unique suffix or share the same suffix as the brand they copy. The agency hasn’t yet released guidance on what it will require of companies to prove that their biosimilars are interchangeable.

In addition, the FDA asked for public comments on how it would impose the suffix policy on biologics that are already on the market without one.

These issues are arising because the FDA only recently received the authority to approve copies of biosimilars. So far it has cleared one: Novartis’ version of Amgen’s cancer drug Neupogen. The active ingredient in Neupogen is filgrastim, and the FDA gave the name filgrastim-sndz to Amgen’s Zarxio.

Because the sndz suffix implies the name of the Novartis unit, Sandoz, that makes the biosimilar, the agency proposed a rule that would change the suffix for Zarxio and certain other biological products already on the market. Novartis’ filgrastim-sndz would become filgrastim-bflm. Amgen’s Neupogen imitation would be called filgrastim-jcwp, and a version of filgrastim that Teva Pharmaceutical Industries makes would be filgrastim-vkzt.

Amgen’s dialysis drug Epogen and Johnson & Johnson’s arthritis treatment Remicade would be called epoetin alfa-cgkn and infliximab-hjmt, respectively, according to the proposed rule.

The FDA’s draft guidance will be published on August 28.

Sources: BloombergBusiness; August 27, 2015; and FDA; August 27, 2015.


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