Assembly approves bill on ‘biosimilar’ medicines

SACRAMENTO, Calif. (AP) — California pharmacists would be allowed to dispense substitute medications that are biologically similar to brand-name treatments under a bill that cleared the state Assembly on Monday.

Biological medicines, which are created from living cells rather than by mixing chemicals, have been used to treat cancer and immune-system disorders.

Those treatments are becoming a fast-growing segment of the pharmaceutical market, with manufacturers also creating medications that are similar to some biological medicines. Unlike traditional generic medications, the so-called biosimilars resemble but are not identical to the biological medication they are replicating.

Federal officials are still in the early stages of developing regulations spelling out when biosimilars can be used. Meanwhile, state legislatures around the country have been debating the issue, with at least five states enacting laws specifying when pharmacists can substitute a biosimilar medication for a brand-name treatment, according to a staff analysis of the California bill.

Under the legislation by Sen. Jerry Hill, D-San Mateo, pharmacists could substitute a potentially cheaper biosimilar medication if it has been approved by the U.S. Food and Drug Administration. The pharmacy must contact the doctor who issued the prescription within five days to let them know which medication was dispensed.

Hill’s SB598 passed the Assembly Monday on a 58-4 vote and returns to the Senate for a final vote.

Several large biotech companies are among the bill’s supporters, along with the California Medical Association and some patient advocacy groups.

“This is a patient-focused bill that will increase access to biologic medicines in a way that facilitates a complete and accurate medical record and manufacturer accountability,” Geoffrey Eich, executive director for regulatory affairs at Amgen, told members of the Assembly Appropriations Committee last week.

Assemblyman Richard Pan, D-Sacramento, said during Monday’s floor debate that the legislation “would reduce state costs and increase patient safety.”

Opponents, including health plans, pharmacists and the state Board of Pharmacy, say state rules for substituting biological medications should wait until federal officials have established regulations.

“The FDA has not approved a single biosimilar for use,” said Assemblywoman Bonnie Lowenthal, D-Long Beach, who voted against the measure. “Beyond that, the FDA has not developed its protocol for substituting a biosimilar for a biological. That’s years away.”

Those opposing the bill also have raised concerns about the requirement to notify physicians about which medication is dispensed, saying it would be a burden on pharmacists and could reduce access to those medications.

The California Public Employees’ Retirement System, the nation’s largest public pension system, wrote to Hill last week, indicating it would oppose the bill unless the notification requirement was removed. The retirement system spent more than $1.5 billion on prescription drugs in 2011, including $236 million on biologic drugs.

“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 increasingly unaffordable health care costs to our members and families,” wrote Danny Brown, chief of CalPERS’ office of governmental affairs.

Pan, a pediatrician, defended the notification requirement Monday. The revised legislation treats biologics and biosimilars equally by requiring that pharmacists notify the prescribing doctor regardless of which medication is dispersed, Pan said.

“It’s helpful, especially in the early stage of prescribing these types of biologics, to be able to track over time exactly what the patient received so that we can better identify side effects,” Pan said.

The requirement to notify physicians would end in January 2017 without additional legislative action.

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