Yesterday, RAPS reported that the FDA is expecting the first interchangeable biosimilars to become available in the U.S. market within the next two years. Interchangeable biosimilars are those that “can be expected to produce the same clinical result as the reference product in any given patient.” In states with automatic substitution laws, interchangeable biosimilars may be substituted for reference products without a doctor calling for substitution. So far, thirty-two U.S. States have enacted such laws, with the most recent being Nebraska.
According to RAPS, FDA’s biosimilar lead Leah Christl said that she expects interchangeable biosimilars will come to market within the next two years, though possibly sooner, and that the first interchangeable biosimilar will likely be reviewed by an FDA advisory committee of outside experts.
Read the full RAPS article for additional details.