Statement by Ralph G. Neas, President and CEO, Generic Pharmaceutical Association, Regarding the Passage of SB 598 in California
Published Online: Wednesday, September 4, 2013
Today’s Senate vote to pass SB 598 is a disappointment, not only to GPhA, but to all those who care about access to affordable medicine. The bill would create unnecessary barriers between Californians and newer, lower-cost versions of biologic therapies, known as biosimilars, particularly interchangeable biosimilars. For the sake of California patients, the California budget, and California taxpayers, GPhA calls on Governor Brown to veto SB 598.
Just last week, the Food and Drug Administration (FDA), the government agency that protects the nation’s food and drug safety, made the important point that efforts like the one in California (backed by Amgen and Genentech) are unnecessary because, “the 2010 law expressly states that an interchangeable biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.”
In addition to being unneeded, this provision in SB 598 will drive up costs for the state. In a letter issued to state legislators explaining their recommendation to oppose unless the bill was amended, CalPERS warned: “If CalPERS is unable to realize the full savings from interchangeable biosimilar products, we may ultimately be forced to raise prescription drug co-payments or health insurance premiums, shifting even more costs onto our members and their families.”
CalPERS is joined by the Los Angeles Times editorial board and more than 30 organizations that oppose the burdensome notification provisions in SB 598; including AARP, California Association of Health Plans, California Pharmacists Association, CVS/Caremark, nine state labor unions, Kaiser Permanente and Walgreens.
Legislation like this has been considered in 19 states and rejected by 11 states, passed with significant amendments in three states, and passed with Amgen and Genentech-backed provisions intact in only one state (North Dakota). In addition to California, two other states are currently considering biosimilars legislation. Florida state legislators passed a law that promotes access to biosimilars without burdensome physician notification requirements.
Priced at approximately $178,000 for 2 courses of treatment, Blincyto will be one of the most expensive cancer medications on the market.
The Generic Pharmaceutical Association welcomes the FDA’s proposed rule to amend its prescription drug and biological product labeling regulations to require electronic distribution of the prescribing information intended for healthcare professionals.
The Generic Pharmaceutical Association has serious concerns about the unbalanced structure of the Trans-Pacific Partnership agreement in its current form.
GPhA has agreed to support compromise automatic substitution legislation that would allow interchangeable biologics to be automatically substituted at the pharmacy. This step brings millions of Americans closer to the day when they will be able to access safe alternatives to costly biologic medicines. Indeed, Express Scripts projects savings of $250 billion in 10 years should only the 11 likeliest biosimilars enter the market.