BIO and PhRMA insist on unique names for biosimilars

July 4, 2012 11:20 AM

In a letter sent to FDA last week, the Biotechnology Industry Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA) requests to use unique individual non-proprietary names for biosimilars.

BIO and PhRMA, emphasize that, unique names are necessary to ensure appropriate pharmacovigilance and it is essential that each biological medicine should have a unique non-proprietary name in the US.

“When considering naming policies for biosimilar products, it is essential that the solution be viable in the long-term. Given that the determination of interchangeability is likely to occur as a second step of a two-step process (i.e., following an initial approval as a biosimilar), a system that assigns unique names to all biologics at the time of market entry is the most straightforward approach that ensures that patient safety is protected” BIO and PhRMA wrote to FDA.

BIO and PhRMA urged the FDA to consider that, adoptation of a system that assigns the same name to products that are similar, but not the same, would creat confusion for physicians and patients and risk patient safety by hindering effective pharmacovigilance.


Source: BIO 


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