FDA proposes adding suffixes to distinguish biosimilar drug names

WASHINGTON, Aug 27 (Reuters) - Cheaper versions of biologic drugs would be identified by a suffix to distinguish them from their more expensive, branded counterparts under draft guidance issued on Thursday by the U.S (Other OTC: UBGXF - news) . Food and Drug Administration.

The FDA said its proposal is designed to prevent inadvertent substitution of non-interchangeable products and to make it easier to monitor and track usage once the products are on the market.

Biologic drugs are made from living organisms and, unlike most traditional drugs, cannot be easily replicated. Copies of biologic products are known as biosimilars as they are similar, not identical, to the original.

The FDA is proposing that original biologic products and their biosimilars share a core drug substance name. That name would be followed by a unique suffix composed of four lowercase letters with no meaning.

As an example, the FDA offered the hypothetical drug replicamab. The original biologic might be named replicamab-cznm while the biosimilar could be named replicamab-hixf.

The agency is seeking public comment as to whether a distinct suffix should be required for products considered interchangeable with the reference version. A product approved as interchangeable may be substituted for the reference product at the pharmacy counter.

A spokesman for the Generic Pharmaceutical Association, Steve Arnoff, said the organization is studying the FDA's proposal and did not have an immediate comment.

The FDA has only approved one biosimilar - Novartis AG (Xetra: 904278 - news) 's Zarxio, or filgrastim-sndz. The drug is similar to Amgen Inc (HKSE: 4332.HK - news) 's Neupogen, or filgrastim, which is used to reduce the incidence of infection in patients taking certain cancer drugs.

In a blog post, FDA officials said the agency must consider what to do to address previously approved biologic products that do not have a suffix and is seeking public comment on the matter. In the meantime it is proposing designating names that contain a suffix for six previously licensed biologic products. (Reporting by Toni Clarke; Editing by Bill Rigby)