California Biologic Substitution Bill Signed by Governor
October 6, 2015 - Today, California Governor, Jerry Brown, signed into law SB 671 (Hill), which regulates the substitution of interchangeable biologic drugs. The bill passed the Senate and Assembly a few months ago, but has been awaiting the the governor signature.
The new law was similar to another proposal by Sen. Hill in 2013, also supported by CRA, which passed both chambers prior to falling to a veto by Governor Brown who dismissed it as “premature.” Significant efforts by CRA and other interested groups helped push the necessity of the legislation this year after the FDA approved the first biosimilar drug in March.
SB 671 includes many of our principles on biosimilar substitution such as only allowing substitution of FDA designated interchangeable biologics as well as the prescriber’s ability to prevent substitution by indicating "do not substitute" on the prescription. The law also provides for communication of a substitution to the prescriber within 5 days of dispensing.
Legislative proposals to regulate the substitution of biosimilars have made significant movement across the country this session. With the signing of the bill in California, 18 states now have laws addressing the substitution of biologics.
Thank you to all of the physicians and other advocates who volunteered all year long to address this issue in California. For more information and resources on this topic, visit the CRA issue page on Access to Biologics.