FDA Faces Challenges in Developing Anxiously Awaited Interchangeability Guidance

October 14, 2015

FDA’s previous guidance establishing a biosimilar naming convention could be the leading cause of the Agency’s delay in releasing the highly anticipated guidance on interchangeability and labelling of biosimilar products.


On August 28, 2015, FDA released the anxiously awaited draft guidance that, when finalized, will establish a naming convention for biological products. That same day, the Agency announced a proposed rule regarding the designation of “official” and “proper” names for biosmilars. Since making these announcements, FDA has remained in the spotlight regarding biosimilar regulation.

To date, FDA has released a total of eight guidances on the topic of biosimilar products; five of which were drafts and the other three final. The most recent of these documents is the above mentioned draft guidance on the naming of biosimilar products. This draft guidance states that biosimilar products will be named by adding four letters to an International Nonproprietary Name (INN), which is assigned by the World Health Organization (WHO) and defined as "a unique name that is globally recognized and is public property," and is used to "facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients."

More than five years after a regulatory pathway for biosimilar products was authorized by Congress, the Senate is wondering why FDA has not published a guidance with information on interchangeability and labelling of biosimilar products. As such, during a biosimilar implementation hearing before the Senate’s Committee on Health, Education, Labor, and Pensions (HELP) on September 17, 2015, Janet Woodcock, M.D., Director, FDA Center for Drug Evaluation and Research (CDER), was asked why we have yet to see any type of guidance or regulation on the topic.

Current Challenges

A recent article in BioPharma-Reporter states that FDA may have put itself in a “catch-22 situation,” as the establishment of an interchangeability guidance should cause the need for this four letter identifier to diminish. Now, BioPharma-Reporter says, FDA may be finding itself in a “trap.”

The increasing pressure on FDA for an interchangeability guidance, and the Agency’s continued delay, could be explained by the previously published guidance. The stalls in the deliverance of such regulation could certainly continue as the Agency works to solve this road block.

While the Senate along with industry professionals continue to patiently await the release of this guidance, it will be interesting to see what FDA does.

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