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WASHINGTON, Aug 27 (Reuters) - Cheaper versions ofbiologic drugs would be identified by a suffix to distinguishthem from their more expensive, branded counterparts under draftguidance issued on Thursday by the U.S. Food and DrugAdministration.
The FDA said its proposal is designed to prevent inadvertentsubstitution of non-interchangeable products and to make iteasier to monitor and track usage once the products are on themarket.
Biologic drugs are made from living organisms and, unlikemost traditional drugs, cannot be easily replicated. Copies ofbiologic products are known as biosimilars as they are similar,not identical, to the original.
The FDA is proposing that original biologic products andtheir biosimilars share a core drug substance name. That namewould be followed by a unique suffix composed of four lowercaseletters with no meaning.
As an example, the FDA offered the hypothetical drugreplicamab. The original biologic might be named replicamab-cznmwhile 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 approvedas interchangeable may be substituted for the reference productat the pharmacy counter.
A spokesman for the Generic Pharmaceutical Association,Steve Arnoff, said the organization is studying the FDA'sproposal and did not have an immediate comment.
The FDA has only approved one biosimilar - Novartis AG's Zarxio, or filgrastim-sndz. The drug is similar toAmgen Inc's Neupogen, or filgrastim, which is used toreduce the incidence of infection in patients taking certaincancer drugs.
In a blog post, FDA officials said the agency must considerwhat to do to address previously approved biologic products thatdo not have a suffix and is seeking public comment on thematter. In the meantime it is proposing designating names thatcontain a suffix for six previously licensed biologic products. (Reporting by Toni Clarke; Editing by Bill Rigby)
