Final approval for California's SB 598 Biosimilars Bill

5 September 2013

A bill updating US State of California’s pharmacy substitution law to allow greater patient access to more affordable Food and Drug Administration-approved biologic medicines is headed to the Governor’s desk after yesterday’s (September 4) overwhelming passage in the Senate in a 30 to two vote (The Pharma Letter August 28).

Senate Bill 598, authored by Senator Jerry Hill (Democrat, San Mateo), will allow pharmacists to substitute a new class of biologic medicines, or “biosimilars,” for a brand biologic when the biosimilar is deemed interchangeable by the FDA and require that a patient’s physician is notified which biologic medicine was dispensed. While the majority of biologic medicines are dispensed and administered by physicians, a small percentage of patients receive them through pharmacies.

The bill has overwhelming bi-partisan support from lawmakers in both the Assembly and Senate and from diverse groups throughout the state including the California Medical Association and hundreds of patient advocate, life-science, business and labor organizations, all of whom value its cost-saving and life-saving benefits.

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