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California closer to get biosimilars bill

06 September 2013 | Regulatory | By BioSpectrum Bureau

US State of California's biosimilar Senate Bill 598 received bi-partisan support from lawmakers in both the assembly and senate

US State of California's biosimilar Senate Bill 598 received bi-partisan support from lawmakers in both the assembly and senate

Singapore: The US State of California's biosimilar Senate Bill 598, which is a pharmacy substitution law to allow greater patient access to more affordable FDA-approved biologic medicines, has received bi-partisan support from lawmakers in both the assembly and senate and from diverse groups throughout the state including the California Medical Association.

The bill will allow pharmacists to substitute a new class of biologic medicines, called 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.

"California policymakers recognize that biosimilars may be approved for the US healthcare market as early as 2014 and without an update to state law patients will not have full access to them," said Mr Joseph Panetta, president and CEO, Biocom, representing more than 500 life science companies, including medical device, diagnostics, biotechnology and biofuels companies, universities, and basic research institutions.

He further added, "SB 598 is timely legislation that provides a balanced framework governing the use of biosimilars and gives doctors and patients more and better choices." 

"As one of the world's largest manufacturers of generic medicines, Actavis supports the bill because it will serve to increase confidence in biosimilar products among patients, physicians and pharmacists, thereby enhancing their acceptance and accelerating the savings they will produce," said Mr Paul Bisaro, president and CEO, Actavis.

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