Biosimilars should carry same generic names as branded biologics, GPhA says

Giving biosimilars unique international non-proprietary names would not enhance safety, group says

WASHINGTON — A trade group for the generic pharmaceutical industry is hoping the Food and Drug Administration will allow biosimilars to share the same generic names as their branded biologic counterparts, saying that giving biosimilars their own generic names would not enhance safety.

The Generic Pharmaceutical Association said Thursday that it had filed a petition with the FDA recommending that all biosimilars the agency approves carry the same international non-proprietary name, or INN, as the branded products they're based upon because they are considered to have no clinically meaningful difference. For example, Hospira's Inflectra, the autoimmune treatment recently approved by the European Medicines Agency, carries the generic name infliximab, the same name as reference product Remicade, sold by Johnson & Johnson and Merck.

"It is simple: biosimilars have no clinically meaningful difference from the reference product, so they should have the same name," GPhA president and CEO Ralph Neas said. "This approach works in Europe; it has worked in the United States for chemical drugs, and it should be the standard worldwide. To upset the naming system in place risks engendering confusion and would have a major negative impact throughout the global pharmaceutical supply chain, potentially jeopardizing patient access across the globe."


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