The California Senate passed a state bill that would impose restrictions on when pharmacists may dispense a biosimilar in place of an innovator product. The California Assembly already passed the bill, which will now be sent to Gov. Jerry Brown. A spokesperson for Brown said the governor does not comment on pending legislation, but Brown will have until Oct. 13 to sign the bill into law.
The California bill would allow substitution of a biosimilar for an innovator product only if FDA declared the biosimilar interchangeable for the specific use; the prescriber had not expressly prohibited use of a biosimilar; the substitution was communicated to patients; the cost to the patient was the same or less than the innovator product; and the pharmacist notified the prescribing physician within five days. The requirement for physician notification would sunset after three years (Jan. 1, 2017). Additionally, the California State Board of Pharmacy would maintain a list of biosimilar products FDA determines to be interchangeable on its website. A spokesperson for the Biotechnology Industry Organization (BIO) said the bill applies only to retail pharmacies.
Despite what you may read in the papers, sometimes legislation that’s supported by innovator pharmaceutical companies is also in the best interest of the public health. This is one of those times.
