(Adds industry, patient group comment)
By Toni Clarke
WASHINGTON, Aug 27 (Reuters) - The U.S. Food and DrugAdministration proposed on Thursday identifying cheaper versionsof biologic drugs with a suffix to distinguish them from their more expensive, brandedcounterparts.
The FDA said its draft guidance is designed to prevent theinadvertent substitution of non-interchangeable products and tomake it easier to monitor and track usage once the products areon the market.
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.
The agency is proposing that originator drugs also contain asuffix, albeit a different one from the biosimilar. As anexample, the agency offered the hypothetical drug replicamab.The original biologic might be named replicamab-cznm while thebiosimilar 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.
The generic drug industry disagrees with the proposal andargues both products should have the same name.
"Adding a random collection of letters to the product'snonproprietary name confers no additional safety benefit, and infact would require the healthcare professional to be armed atall times with a code-breaking reference," Dr. Bertrand Liang,chairman of the Biosimilars Council, a division of the GenericPharmaceutical Association, said in a statement.
Brand name drugmakers and some patient groups wantdifferences between the products to be defined. A coalition ofpatient advocacy groups known as Patients for Biologics Safetyand Access said distinguishable names are needed "to ensureaccurate tracking of medication utilizaton and adverse events."
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 and AlanCrosby)
Glaxosmithkline (GSK)