Are Biosimilar Names Key to Biosimilar Fates?


[author: Michael Shuster]

"People's fates are simplified by their names" goes the quote from the Bulgarian novelist and playwright Elias Canetti. Whether this is indeed true for people is debatable but for biological drugs names are apparently critical, or so we can gather from recent warring between branded and generic industry organizations. Last week industry organizations BIO and PhARMA issued a rare joint letter to FDA commissioner Margaret Hamburg strongly supporting the use of unique names for all biosimilar products, whether deemed fully 'interchangeable' or merely biosimilar. The Generic Pharmaceutical Industry, understandably, disagreed, in its own letter to Commissioner Hamburg.

The naming situation with biological drugs is more complicated than for small molecule drugs because even interchangeable biologics are not identical in the strict chemical sense that small molecule drugs are identical.

Thus there can only be one trastuzumab ("herceptin"), and a biosimilar version, even an interchangeable one under the law, could, at best, be called "biosimilar trastuzumab" - but BIO would prefer FDA require such a biologic to have an entirely new name. For the generics industry, the marketing burden of educating doctors (and patients) that a drug with an entirely new name is actually biosimilar herceptin would be formidable.

It will be up to FDA to decide on the naming rules, and the rest will be up to fate (or marketing genius).


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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