FDA Releases Draft Guidance on Naming Biological Products

The FDA last week released long-awaited draft guidance on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a different four-letter suffix.

Under this system, applicants would propose up to three suffixes to be included in the proper name designated by the FDA at the time of licensing.

The suffix would consist of four lowercase letters that are unique and devoid of meaning and should not make any misrepresentations about safety or efficacy, or be mistaken with the name of a currently marketed product, according to the guidance. For example, the nonproprietary name of a reference product could be replicamab-cznm, while a biosimilar to that product could be replicamab-hixf.

The proposed naming convention is meant to prevent inadvertent substitution for products that are not interchangeable, and make it easier to track usage of products after they are on the market.

Using a shared core name would indicate a relationship among products, the FDA notes. By placing the identifier as a suffix, instead of a prefix, biological products with the same core name would be grouped together in electronic databases.

Applicants would request FDA review of a proposed suffix during the IND or BLA phase. If drugmakers later wanted to change the suffix, they could do so via a prior-approval labeling supplement, the guidance says.

For interchangeable biological products, the FDA is seeking industry feedback on whether the nonproprietary name should include a distinct suffix or should share the same suffix as the reference product.

Release of the guidance dovetailed with a proposed rule to designate nonproprietary names for six previously approved biological and biosimilar products. One of those is Sandoz’s Zarxio biosimilar of Amgen’s chemotherapy drug Neupogen, which was approved in March using the placeholder name filgrastim-sndz.

Industry Reaction

GPhA was quick to slam the proposed guidance.

Bertrand Liang, chairman of the group’s Biosimilars Council, said biologics and biosimilars should be required to have the same international nonproprietary name with no added FDA-designated suffix. Adverse events and product recalls for small-molecule and biologic drugs are already successfully identified using the national drug code, lot number and company name, and there’s no compelling evidence that biosimilars should be handled differently, he tells DID. Liang adds that there is already a precedent for shared names — e.g., erythropoietin, somatropin, interferon — that has not resulted in any known patient safety issues.

Liang also notes that shared INNs without suffixes are used in the EU, Canada, Australia and Japan with no ill effects. Adding a random collection of letters to the product’s nonproprietary name confers no additional safety benefit and, in fact, would require healthcare professionals to be armed at all times with a code-breaking reference, he says.

BIO and the Biosimilars Forum welcomed the guidance. The distinct suffixes support the Biosimilars Forum’s argument that biosimilars should have separate codes for Medicare reimbursement purposes, the group said.

Comments are due by Oct. 27. Read Nonproprietary Naming of Biological Products at www.fdanews.com/8-15-Biological-Naming.pdf. — Jonathon Shacat