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June 1 — The FDA signaled June 1 that it's sticking with its proposed plan to identify brand biologics and biosimilars with suffixes.
But the Food and Drug Administration appeared to be veering from its original plan for suffixes of randomly picked four letters and instead will ask applicants for brand biologics and biosimilars for suffix suggestions.
In an advance copy of a Federal Register notice scheduled to be released June 2, the FDA said it had submitted an information collection to the Office of Management and Budget (OMB). The information collection is the FDA's request that applicants propose a suffix of four lowercase letters to distinguish their products.
The FDA issued a draft guidance on nonproprietary naming for biological products, including biosimilars, on Aug. 27, 2015, that presented its plan for using the suffix as an identifier (9 LSLR 1033, 9/18/15).
In the Federal Register notice, the agency asked for comments on the information collection. It noted that those who submitted written comments on the draft guidance generally supported the proposal to designate a suffix, although some thought that its estimate for the time burden for applicants in submitting suffixes was low.
There had been some uncertainty about the FDA's commitment to the suffix-identifier plan because of opposition from some industry sectors and because in its April draft biosimilar labeling guidance, it had appeared to be ambivalent on the naming issue (10 LSLR 08, 4/15/16). But the notice to the OMB would appear to seal the deal.
A biosimilar is a biological product that is approved by the FDA based on a showing that it is highly similar to an already approved biological product, known as a reference product (RP). The biosimilar also must show it has no clinically meaningful differences in terms of safety and effectiveness from the RP.
The FDA's draft guidance on naming for RPs and biosimilars proposed that they have nonproprietary names that share a core drug substance name and, to better identify each product, an FDA-designated suffix that is unique for each product. This suffix would be composed of four lowercase letters, which the FDA originally suggested wouldn't carry any meaning.
The immediate reaction was that the branded biologic industry generally praised the FDA's proposal while the generic industry and a pharmacy group said the proposal would create confusion and limit access to these products.
In written comments on the draft guidance, the Biosimilars Forum, the American Pharmacists Association, the U.S. Pharmacopeial Convention and America's Health Insurance Plans all expressed concerns about the proposed naming policy and requested changes (9 LSLR 1265, 11/13/15).
In its Federal Register notice, the FDA indicated that based on written comments on the draft guidance, most supported its proposal to designate a suffix.
“Many comments suggested that a meaningful, distinguishable suffix may help to improve pharmacovigilance [the monitoring of pharmaceuticals and biologics after they have been licensed], enhance safety and facilitate identification between biological products,” the FDA wrote.
According to the FDA, some comments supported use of a random suffix to avoid creating an unfair advantage for specific manufacturers, and others said that the current practices of FDA and non-FDA entities for identifying biosimilar and interchangeable products are sufficient for pharmacovigilance.
The first biosimilar approved by the FDA, Sandoz's Zarxio, a biosimilar of Amgen's Neupogen (filgrastim), was approved before the draft naming guidance was issued (9 LSLR 328, 3/20/15). The FDA gave it a placeholder name whose suffix wasn't composed of random letters—filgrastim-sndz, which is the core drug substance name plus a suffix based on the sponsor's name.
The second biosimilar approved by the FDA, Pfizer Inc.'s Inflectra, a biosimilar of Johnson & Johnson's Remicade (infliximab), was named with a suffix of randomly assigned letters— infliximab-dyyb (10 LSLR 08, 4/15/16).
An FDA spokeswoman declined to comment on when the FDA might issued a final naming guidance.
Comments must be received within 30 days of publication of the Federal Register notice and should include the FDA docket number FDA-2013-D-1543.
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The pre-publication text of the Federal Register notice is at http://src.bna.com/fvV.
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