Utah passes biosimilar substitution law
The State Senate and Governor Gary Herbert signed House Bill 279 into law this week, giving pharmacies the right to substitute a prescribed biologic drug with a biosimilar.
Under the law, substitution may happen only with drugs the US FDA has declared “interchangeable”. Patients and doctors must be informed of the switch by the pharmacist, and prescribing doctors have the right to block substitution. Pharmacists are required to keep a record of the brand change.
The bill updates the 2013 Pharmacy Practice Act.
Biosimilar vs ‘interchangeable’
The head of biotech industry group BIO welcomed the law. “This law will benefit Utahns when the first interchangeable biologics are approved by the FDA,” said Jim Greenwood. “When they become available, these therapies will be safe, effective and similar to innovator biologics.”
The only biosimilar currently approved in the US is Sandoz’s Zarxio, a rival to Amgen’s originator drug Neupogen (filgrastim).
But the FDA approved Zarxio only as a biosimilar and not as an interchangeable drug, meaning pharmacists cannot dispense it under a Neupogen prescription.
The FDA has said it expects to receive applications for interchangeable biosimilar approvals this year.
Biosimilar substitutions has been up for debate in the US, with California and Illinois last month proposing bills allowing switches.
Eight states have legislated interchangeability, and a further thirteen have tried to pass such laws.
Utah Governor Gary Herbert also hit the headlines last week when he signed a law allowing execution by firing squad.
