California Governor to Consider Legislation Regulating the Substitution of Biosimilars
August 31, 2015 - Today the California Senate concurred with Assembly amendments to SB 671 (Hill), which will regulate the substitution of biosimilar drugs. CRA will continue to voice its support for this legislation by urging the Governor to sign it into law.
SB 671 includes CRA principles on biosimilar substitution. Of note are provisions only allowing substitution of FDA designated interchangeable biologics, prescriber ability to prevent substitution by writing “do not substitute” on the prescription, and communication of a substitution to the prescriber within 5 days of dispensing.
SB 671 is similar to CRA-supported legislation sponsored by Sen. Hill in 2013, which passed both chambers prior to falling to a veto by Governor Jerry Brown who dismissed it as “premature.” This year the landscape looks far better for passage. SB 671 is ripe as the FDA approved the first biosimilar drug this March. This important milestone means that the discussions around biosimilar bills in state legislatures are no longer conceptual.
For more information and resources, visit the CRA issue page on Access to Biologics.
- SB671: Regulation of Biosimilar Substitution