A couple weeks ago, Oregon passed a law that allows pharmacists to automatically substitute a biosimilar for the reference branded biologic. According to this new legislation, before a biosimilar can be automatically substituted, it must be approved by the FDA as an “interchangeable” biosimilar, and the prescriber must not have forbidden the substitution. Under the Oregon law, “interchangeable” has the same meaning as set forth in 42 U.S.C. §262(k)(4), i.e., the biosimilar produce the same clinical result as the reference product in any given patient, and the risk in terms of safety or diminished efficacy of switching between use of the biological product and the reference product is not greater than the risk of using the reference product without a switch. Oregon is the 18th American state to pass automatic substitution laws.
Stay tuned to the Big Molecule Watch for further developments on automatic substitution.