CHI NEWS: CHI Vice President Provides Testimony on Patient, Physician Notification of Biosimilar Substitution
(LA JOLLA, Calif., April 8, 2013) – California Healthcare Institute (CHI) Vice President of State Government Affairs Eve Bukowski today provided testimony before the Senate Business, Professions and Economic Development Committee on the importance of notifying physicians when a patient’s biologic prescription has been substituted with a biosimilar drug. Bukowski, who was diagnosed with stage-four colon cancer, spoke from personal experience and urged the committee to consider patients in the process.
“All of us with diseases treated with biologic medicines understand the instability of our health and the risks of side effects associated with our treatments. It’s a risk we are willing to take for the benefits we receive,” Bukowski said. “Informing the physician of a substitution is not only consistent with current pharmacist-physician interaction, it’s a simple precautionary step.”
Unlike their pharmaceutical counterparts, biotech drugs are made from living organisms and derive from more complex manufacturing processes involving sensitive fermentation and purification. Biosimilars are products “highly similar to” or “interchangeable” with a U.S. Food and Drug Administration-licensed biological product.
New legislation known as SB 598 and authored by Sen. Jerry Hill (D-San Mateo) would regulate the dispensing of biosimilars. It would require patient and physician notification of biosimilar substitution and that the full name and manufacturer be indicated on the medicine’s label.
“SB 598 recognizes that because biologic medicines are not the same as chemically-based generic medicines they need their own set of rules,” Bukowski said.
The committee also heard from Geoffrey Eich, executive director of regulatory affairs at Amgen.
California is known as the “birthplace of biotechnology,” where life-saving biologics such as Avastin and Epogen were developed. The state’s biopharmaceutical industry employs 42,886 people, more than any other state in the nation. The industry is responsible for producing innovative products for treating heart disease, cancer, diabetes, multiple sclerosis and Alzheimer’s disease that serve to benefit millions of patients in the United States and around the world.
Click here to view Bukowski’s testimony.
CHI represents more than 275 leading biotechnology, medical device, diagnostics, and pharmaceutical companies, and public and private academic biomedical research organizations. CHI’s mission is to advance responsible public policies that foster medical innovation and promote scientific discovery. CHI’s website is www.chi.org . Follow us on Twitter @calhealthcare, Facebook, LinkedIn and YouTube.