Last week, legislation to regulate the dispensing of biosimilars, known as SB 598 and authored by Sen. Jerry Hill (D-San Mateo), passed the California State Senate overwhelmingly, with 29 voting in favor, four voting against and six abstaining.
As the statewide public policy association representing California’s innovative life sciences sector including biotechnology, pharmaceutical, medical device and diagnostics companies, venture capital firms, research universities and institutes and its 275,000 workers, CHI strongly supports this legislation and applauds Sen. Hill for his leadership and efforts in championing the passage of SB 598.
Biosimilars are copies of an original biologic medicine and hold the promise of providing similar results as the original biologic at a lower price. However, unlike generic medicine, biosimilars are not structurally identical to the biologic products they seek to copy; thus the name biosimilar. Due to the sensitive nature of biologics, the slightest variation from the original biologic medicine can result in an immune response or other patient side effects.
“Today’s bipartisan vote is a victory for patient protection,” said Eve Bukowski, CHI’s vice president of state government affairs. “SB 598 recognizes that because biologic medicines are not the same as chemically-based generic medicines additional patient protections are called for.”
Under SB 598, pharmacists would be allowed to substitute a biosimilar for a brand biologic when the biosimilar is deemed interchangeable by the FDA. It would also require that a patient’s physician is notified when a biosimilar medicine is substituted for a medication the doctor originally prescribed.
CHI represents companies responsible for making both innovator biologics and companies seeking to create biosimilars of these lifesaving medicines. 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” a U.S. Food and Drug Administration-licensed biological product.
The legislation now moves to the Assembly for further consideration.
Click here to view CHI’s letter supporting SB 598.
Click here to read Bukowski’s April 2013 committee testimony in regarding SB 598.
Source: CHI press release