Suffix to distinguish biosimilars now
Copies of biologic products knows as biosimilars will now have suffix to their names to distinguish them from their branded counterparts says USFDA
USFDA is reported to have drafted a proposal for a new brand name guideline to distinguish the cheaper versions of biologic drugs, also known as biosimilars, from their expensive, branded counterparts. 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.
Designed with an objective 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, the new name of the generic drug would be followed by a unique suffix composed of four lowercase letters with no meaning.
The FDA is proposing that original biologic products and their biosimilars share a core drug substance name. 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, as reported by Reuters.
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's Zarxio, or filgrastim-sndz. The drug is similar to Amgen Inc's Neupogen, or filgrastim, which is used to reduce the incidence of infection in patients taking certain cancer drugs.
USFDA is reported to have drafted a proposal for a new brand name guideline to distinguish the cheaper versions of biologic drugs, also known as biosimilars, from their expensive, branded counterparts. 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.
Designed with an objective 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, the new name of the generic drug would be followed by a unique suffix composed of four lowercase letters with no meaning.
The FDA is proposing that original biologic products and their biosimilars share a core drug substance name. 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, as reported by Reuters.
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's Zarxio, or filgrastim-sndz. The drug is similar to Amgen Inc's Neupogen, or filgrastim, which is used to reduce the incidence of infection in patients taking certain cancer drugs.
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