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Docs to FDA: Biosimilars should have different names than branded drugs

August 19, 2014
Yesterday, Fierce Biotech highlighted a letter written by more than 10 medical associations and 20 individual specialists to FDA Commissioner Margaret Hamburg saying that biosimilars "must have distinguishable nonproprietary names.

The FDA drafted a set of rules for biosimilars in 2012, sparking a debate on whether those drugs should carry the same generic names as the originator products. Now, some doctors are weighing in on the issue, urging the FDA to require biosimilars to have distinguishable names.

The physicians argued that using different names would aid in the tracking of adverse events and prevent confusion over copycat biologics when the biosimilar isn't approved for all the same uses as the original. In those cases, they wrote, "a misunderstanding can be potentially dangerous."

Check out the physicians' letter to the FDA and read the WSJ blog item here.