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Dispute over the names for biosimilars

Posted in Pharmaceutical Advertising

As reported by DrugStoreNews.com, there has been a lot of discussion in the biotechnology world over the appropriate names of follow-on biologics.  “Follow-on biologics,” also known as “biosimilars,” are “biologic medical products whose active drug substance is made by a living organism or derived from a living organism by means of recombinant DNA or controlled gene expression methods” (Wikipedia).

Because generic pharmaceutical drugs are by law chemically identical to branded drugs, brand name drugs and generic drugs carry the same name.  As such, companies that manufacture biosimilars demand this standard and practice to be used for their products.  For example, Enbrel is an autoimmune drug made by the company Pfizer and Enbrel’s generic name is etanercept.  Generic drug companies in Europe have openly said that the use of the same generic name has not been a problem over the past six years of their availability.

However, some biotech companies assert that biosimilars are actually made from different cell lines, and are therefore chemically unique, thus requiring separate nomenclature and review.

Over the past week, half a dozen US senators have taken concern over the recent development regarding biosimilar naming, as Biotechnology Industry Organization is a trade group that is at risk for losing billions in sales if biosimilars are allowed to use the same names as the drugs to which they are similar.  The Organization is worried about the competition these biosimilars will bring and possible confusion for American citizens.

In the end, what is most relevant here is the risk for confusion among consumers and the medical community.  If doctors believe in a certain case that a biosimilar ought to be avoided in clinical use, but the desired generic or branded drug carries the same name as the biosimilar, it isn’t unreasonable to believe that there may be problems.  Any drug that is chemically unique ought to have a unique name, regardless of how similar it is to another chemical.