Bill Regulating Biosimilar Drugs Vetoed

by Bob Norberg, California Healthline Contributing Reporter

A bill that would have allowed "biosimilar" drugs to be substituted for biologic drugs was vetoed over the weekend by Gov. Jerry Brown (D), who said it was premature to pass the law until the Federal Drug Administration has worked out standards for the new drugs.

SB 598, authored by Sen. Jerry Hill (D-San Mateo), would have allowed pharmacists to dispense biosimilar drugs as lower-cost replacements for biologics, a policy Brown said he supports.

Biologics are basically copies -- or generic versions -- of biologics, a distinct type of pharmaceutical different from chemically synthesized drugs. Biologics are created by biologic processes.

Biosimilars have yet to be approved by the FDA but are expected to be on the U.S. market by 2015.

Made in living cells and often expensive, biologics include cancer drugs such as Avastin and Herceptin and arthritis medications Enbrel and Humira. The Affordable Care Act requires the FDA to approve and regulate copies of biologics, known as biosimilars rather than generics because they are not exact copies of the original.

One sticking point for the California bill was a requirement that pharmacists be required to notify physicians prescribing the drugs within five days of making the change. Some stakeholders said that would imply the drugs are not as good as biologics and are to be avoided.

Opponents, including CalPERS, overseer of the state employees retirement system, agreed with the governor that the state should wait until the FDA acts first.

Hill said delaying the regulations could mean that if the FDA were to approve a biosimilar next year, Californians would not be able to take advantage of the less-costly drug.

Hill also said he believes notification is important because biosimilars by the nature are similar to but not exactly the same as the biologics they're replacing.

"We will continue this conversation. We have to," Hill said. "We want to dispense biosimilars. And second, if you or a loved one were suffering from a life-threatening disease, and you know every biologic is different and could cause a reaction, wouldn't you want your physician to know what you are putting into your body?"

Other bills vetoed by Brown would have required health care plans to cover medical expenses for the treatment of fertility preservation and fund spinal cord research.

AB 912 by Assembly member Sharon Quirk-Silva (D-Fullerton) would have required health care service plans and health insurers to cover, on a large group basis, medically necessary expenses for fertility preservation when a medical treatment causes infertility.

It was meant to cover female cancer patients who, facing chemotherapy and the possibility of infertility choose to have their eggs frozen and preserved for future use, or a man making the same decision to have his sperm frozen. Patients now have to pay those costs.

"While I am disappointed that AB 912 was vetoed, I will continue to look for opportunities to ensure that patients with severe diseases such as cancer do not have to make the difficult choice between receiving life-saving medical help and starting a family," Quirk-Silva said in a statement.

The bill was supported by a number of medical groups dealing with cancer and reproductive services and opposed by business and insurance groups.

It is difficult, however, to gauge what the impact of the law would have been, since cancer is largely a disease for older people and not of those who are at a child-bearing age, said Jose Gonzalez, executive director of the Northern California Association of Oncologists, which supported the bill.

"We thought it was an important part of a patients' rights to have," Gonzalez said.

A study by the state Senate Appropriations Committee estimated the health care cost to CalPERS of $70,000 per year. It also said it would not impact the state's essential health benefits nor apply to health insurers and health plans selling policies in the California Health Benefit Exchange.

Brown in his veto message on Friday said large group employers already have the ability to negotiate benefit packages, such coverage was not included in the essential health benefits adopted by the Legislature last year, and requirements for additional benefits should not be considered until California implements the necessary reforms for the federal Affordable Care Act.

AB 714 by Assembly member Bob Wieckowski (D-Fremont) would have provided $1 million from the state general fund to the University of California's spinal cord injury research fund.

The independent fund was established by the Roman Reed Spinal Cord Injury Act, passed in 2000, named after Roman Reed, a Chabot College, Hayward, football player who suffered paralysis after being injured in a game.

The fund supports research at UC-Irvine's Reed-Irvine Research Center, but no longer receives state funds.

Brown in his veto message said Friday that in January he approved an increase of $511 million to the University of California over the next four years, and because there is enough flexibility for the university to make its own funding decisions, he doesn't support ear-marks.

"I am very disappointed that Governor Brown has vetoed crucial funding for spinal cord injury research in California," Wieckowski said in a statement. "This bill would have aided our biotech industry, advanced health care research in our universities and, most importantly, helped improve the quality of life for thousands of Californians living with paralysis."

"With federal research funding being slashed, California should step up with dedicated funding to stay at the forefront of this kind of cutting-edge research." Wieckowski said.

Wieckowski made an unsuccessful attempt to get funds for the research fund during the 2011-2012 Legislative session with Assembly Bill 190, which would have put an additional $3 fine on state and local traffic violations. It would have raised $11 million, but the bill died in the Assembly Appropriations Committee.


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