California Biosimilar Bill Forwarded to State's Senate

Another state sets up the pathway for biosimilar substitution; however, the proposed legislation comes with restrictions on that practice.

The California State Assembly on August 26, 2013, approved the most recent biosimilar substitution bill, setting it up for a vote within the state’s senate.

Under the bill, which would be forwarded to Gov. Jerry Brown if passed by the senate, pharmacists would be permitted to substitute biosimilar products for a referenced biologic product if (1) the FDA has deemed the biosimilar product to be interchangeable with the prescribed medicine for the specified use and (2) the prescriber has not prohibited substitution.

The ability to substitute biosimilars comes with caveats, however. Prescriptions filled before January 1, 2017, would require pharmacies to notify the prescriber of substitution or enter the substitution in a patient record within 5 days of product selection. Pharmacists (1) could not select an interchangeable biosimilar product unless the cost to the patient was equal to or less than that of the reference biologic and (2) must notify patients of the product change.

Another provision in the bill would require the California State Board of Pharmacy to maintain a link to the current list of the FDA’s interchangeable biosimilar products, providing a list is available. The link must appear on a publicly accessible area on the board’s website.

The most recent bill text also notes that a conscious violation of the bill terms would amount to a misdemeanor, thus creating new crimes and the imposition of a state-mandated correction program.

The bill’s provisions do not apply to the administration of vaccines, section I of the proposed bill notes.

A similar bill, AB-1139, was introduced in the California Assembly on February, 22, 2013. Its first committee hearing was cancelled at the request of the bill author, according to the state’s legislative information page.

The California assembly’s action is the latest victory for biosimilar restrictions. Backed by pharmaceutical manufacturers Amgen and Genentech, the biosimilar restriction bills have only seen limited success, according to an August 22, 2013, article on Forbes. Of the 4 states enacting restriction bills, only 1 state, North Dakota, passed the bills without a sunset clause on the restrictions.

The Biotechnology Industry Organization, however, does not view the restrictions as such. Instead, the organization believes the restrictions provide the avenue for biosimilar substitution while also acknowledging the therapy’s complex makeup.

“This is another important step taken by the California State Legislature to ensure patients and physicians who are managing chronic conditions are made fully aware of which biologic drug is ultimately administered by the pharmacist,” James Greenwood, President and CEO of BIO, said in a statement.

“. . . Recognizing the importance of communication between the [patients, physicians, and pharmacists] is particularly relevant when a physician prescribes a biologic medicine, which may be personalized to a patient’s unique course of treatment.”