FDA Expects Approvals For Interchangeable
Biosimilars Within 2 Years

In 2010, the pathway for biosimilar approvals was set up by the FDA. Since then, the FDA has approved only five biosimilars, with none of the approvals being for interchangeable biosimilars. Interchangeable biosimilars are already in use in Europe, and there has been conflicting information about when they would hit the market after regulatory approval in the US.

The FDA is barred from releasing specific information about drug approval applications that have been submitted to the agency because of confidentiality laws. However, that doesn’t stop the agency from making generalized predictions. Leah Christl, the FDA’s biosimilars lead, spoke at the DIA’s annual conference in Chicago last week. At the confence, Christl said that she believes interchangeable biosimilars will come to the US market within the next two years, with a possibility of the drugs hitting the market even sooner. Christl noted that the first interchangeable biosimilar drug will likely face a review from an FDA advisory committee comprised of outside experts.

Biosimilar interchangeability is defined by the Biologics Price Competition and Innovation Act. The law established the biosimilars pathway for FDA approval, and it also stated that an interchangeable biosimilar must produce the same clinical result as the reference product in any given patient. In the US, an interchangeable biosimilar could be substituted for the reference product without a physician explicitly asking for the substitution.

Experts believe that the FDA’s work with biosimilar approvals will improve as the biosimilar user fee program is reauthorized. After the reauthorization, the FDA will be able to hire more staff members, improve the scope of industry meetings, and make other improvements, such as written responses to questions when a meeting might not be necessary.





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