Biosimilars Bill Passes California Assembly
August 28, 2015 - CRA applauds the California Assembly's passage of SB 671 (Hill), which will regulate the substitution of biosimilar drugs. The bill passed the Assembly by a unanimous vote on August 27, and now awaits Senate concurrence with the Assembly amendment before it may be sent to the governor for his consideration.
This legislation 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.
Legislative proposals to regulate the substitution of biosimilars have made significant movement across the country this session. Approximately 20 states have considered biosimilars legislation this year, including 10 that have been signed into law.
For more information and resources, visit the CRA issue page on Access to Biologics.
- SB671: Regulation of Biosimilar Substitution
- H671.201508271105: Biosimilar substitution