BioCentury
ARTICLE | Politics & Policy

FDA says state biosimilar bills 'worrisome'

August 29, 2013 12:33 AM UTC

An FDA spokesperson said the agency does not have a position on any particular state legislation covering the use of biosimilars but that "efforts to undermine trust" in biosimilars are "worrisome and represent a disservice to patients who could benefit from these lower cost treatments." The comment came in a statement after the California Assembly passed a bill that would restrict when pharmacists may dispense a biosimilar in place of an innovator product. Not including California, at least five other states are advancing bills that would impose biosimilar dispensing requirements on physicians and pharmacists. Earlier this year, Virginia became the first state to sign such a bill into state law (see BioCentury Extra, March 22).

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 for prescriptions filed prior to Jan. 1, 2017. The bill also would require the California State Board of Pharmacy to maintain a list of biosimilar products FDA determines to be interchangeable on its website. The Biotechnology Industry Organization (BIO), which supports the California bill, said the measures would ensure patients and physicians "are made fully aware of which biologic drug is ultimately administered by the pharmacist." The bill now goes back to the California Senate to be reconciled with the Senate's version. ...