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Biosimilars Bill Secures Final Approval in California State Legislature - Awaits Governor’s Signature

Thu, 09/05/2013 - 8:37am

A bill updating California’s pharmacy substitution law to allow greater patient access to more affordable FDA-approved biologic medicines is headed to the Governor’s desk after passage in the Senate in a 30 to 2 vote.

Senate Bill 598, authored by Sen. Jerry Hill (D-San Mateo), 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.

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.

“California policymakers recognize that biosimilars may be approved for the U.S. healthcare market as early as 2014 and without an update to state law patients will not have full access to them,” said Joseph Panetta, president and CEO of BIOCOM, representing more than 500 life science companies, including medical device, diagnostics, biotechnology and biofuels companies, universities, and basic research institutions. “SB 598 is timely legislation that provides a balanced framework governing the use of biosimilars and gives doctors and patients more and better choices. All three of California’s policy-based life science trade associations, representing virtually all of California’s life sciences companies, strongly support the bill and ask for the Governor’s signature,” said Panetta.

“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 Paul Bisaro, president and CEO of Actavis, (formerly Watson Pharmaceuticals Inc.), the world’s third largest generic pharmaceutical company, developer of biosimilar pharmaceutical products and a California employer with facilities in Corona that employ approximately 800 people.

“The Western States Council of Sheet Metal Workers wants to ensure that our members receive the best health care available while having available all reasonable cost containment mechanisms,” stated Scott Wetch, legislative advocate of the Council. “We believe our health care plan can provide access to biologics and biosimilars and better protect our members with the prescriber notification requirement set forth in this bill and we encourage the Governor to sign it,” said Wetch.

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