South San Francisco, Calif. — October 14th, 2013 — We will continue to work with the California legislature and state governments across the country to ensure safe access to biosimilar products.
Genentech is disappointed with California Governor Jerry Brown’s veto of Senate Bill 598, which would have given patients with serious illnesses access to lower cost, FDA-approved biosimilar medicines when they become available. Without legislation to conform California state law to the Affordable Care Act, patients who receive biologics at their pharmacy may not benefit from these treatment options. SB 598 received overwhelming bipartisan support in the legislature and was supported by hundreds of patient, physician and business groups, in large part, because it helped ensure patient safety through a provision to notify physicians about the biologic medicines dispensed at the pharmacy.
In his veto statement, the Governor said that physician notification is premature. However, as of June 19, 2013, the FDA's Center for Drug Evaluation and Research (CDER) had already received 56 meeting requests to discuss biosimilar development programs for 12 different products, and, in fact, had held 40 meetings. CDER has also received 17 Investigational New Drug (IND) applications for biosimilar development programs and additional earlier-stage biosimilar development programs are underway. Given that biosimilars may be available to patients in 2014, the state legislative initiative in California is timely and necessary.
Genentech will continue to work with the California Legislature, state governments across the country, and the healthcare community to ensure patients have access to biosimilar products in a safe, responsible and transparent manner.
Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.