Ever since the FDA drafted a set of rules for biosimilars in 2012, a debate has been raging over whether those drugs should carry the same generic names as the products they emulate. Now, some doctors are weighing in on the issue, urging the FDA to require biosimilars to have different names than branded biotech drugs.
More than 10 medical associations and 20 individual specialists signed a letter to FDA Commissioner Margaret Hamburg late last week saying that biosimilars "must have distinguishable nonproprietary names," primarily "to alert physicians that each product, while safe and effective, may differ slightly" from the original.
The physicians also argued that using different names would aid in the tracking of adverse events. Furthermore, they said, distinctive names on copycat biologics would help prevent confusion 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."
The physicians' letter lands them on the same side of the naming debate as the branded pharma industry. In 2012, two of the biggest pharma trade groups, PhRMA and BIO, sent a letter to Hamburg imploring her to require separate names for biosimilars.
Among the groups that signed last week's letter was the Alliance for Patient Access, which represents doctors but is largely funded by pharma companies. In fact, the group's director, Brian Kennedy, tells The Wall Street Journal blog Pharmalot that some of its contributors--notably Amgen ($AMGN) and Pfizer ($PFE)--are developing biosimilars themselves.
On the other side of the issue is a coalition of pharmacies, health insurers, unions and pension plans, which wrote the FDA last month making a case for generic naming. They argued that keeping the names uniform would make it easier to substitute cheaper biosimilars for the originals, in turn cutting down on spending. Furthermore, they said, it would alleviate confusion among doctors and patients and reduce medication errors.
There's no question the naming issue will need to be resolved soon. In July, Novartis ($NVS) filed the first biosimilar application with the FDA for a version of Neupogen, Amgen's white blood cell booster. And last week, Celltrion of South Korea filed for approval for a biosimilar of Remicade, the blockbuster anti-inflammatory treatment from Johnson & Johnson's ($JNJ) Janssen unit. Celltrion and its partner Hospira ($HSP) have already nabbed approval in Europe, becoming pioneers in a market for biosimilars that analysts estimate could hit $200 billion this decade.