California law surrounding innovative new biologic and biosimilar medications has returned for the 2015-2016 session.
Because of the complexity of creating these drugs, it is virtually impossible to create identical “generic” products of biologics. Instead, biologics have what are called biosimilar or interchangeable biological products that meet varying degrees of similarity. This is especially important today with the introduction of interchangeable biologics into state markets continuing to grow closer.
Last session, Senator Hill introduced SB 598 which would have authorized a pharmacist to substitute an interchangeable biosimilar for a prescribed biological with some limitations. CRA voiced its support throughout the process, from the initial committee hearing all the way through both chambers and to the Governor’s Office. Regrettably, the Governor vetoed SB 598 on October 12, 2013, explaining it was premature.
Now, with the U.S. Food and Drug Administration (FDA) approval of the first biosimilar product this year, an increasing numbers of state legislatures, including California, have recognized the importance of passing this important legislation into law.
Senator Hill has once again introduced a biosimilars bill, SB 671, which seeks many of the same provisions including provider notification, only substituting interchangeable biosimilars, and a physician’s ability to prevent a substitution. The prospects for this legislation look good, with many more parties adding in their support this year.
CRA supports the premise of the legislation and is working with other patient and provider groups including CSRO and ACR to ensure that the final law supports all concerns regarding the introduction of these important drugs.
California Advocacy Summit — CRA and Arthritis Foundation, Pacific Region advocated in support of SB 671 during their joint California Advocacy Summit on April 20 & 21, 2015. Provider and patient advocates stressed the importance of regulating biosimilar substitution and voiced their support for SB 671 while meeting with legislators from across the state.
- CRA Letter to Governor Brown in Support of SB 671
- CSRO Biosimilars Issue Page
- ACR Biosimilars Position Statement on Biosimilars
- Arthritis Foundation Position Statement on Biosimilars
- CRA Letter To Governor Brown In Support of SB 598 (2013-14 Legislative Session)
UPDATE: As of September 3, the bill awaits the Governor’s consideration.