Although the U.S. Food and Drug Administration (FDA) has yet to release its final biosimilars guidelines, federal healthcare reform has created a pathway for the FDA to approve biosimilars, and each state in the union may draft and approve its own legislation. Lawmakers are carefully considering how to encourage innovation in drug development while giving patients access to affordable biologic treatments. So far, five states—Florida, North Dakota, Oregon, Utah and Virginia—have enacted laws specifying the circumstances under which pharmacists could substitute biosimilars for reference products. Three of the laws—enacted in Oregon, Utah and Virginia—include a sunset date.

 

Similar legislation has failed to pass in 11 states: Arizona, Arkansas, California, Colorado, Delaware, Illinois, Indiana, Maryland, Mississippi, Texas and Washington. Two states, Arkansas and Indiana, have referred biosimilar legislation to a study committee for further review. Legislation is pending in two more states, Massachusetts and Pennsylvania.

 

SB 598 would have updated California pharmacy law to allow biosimilars deemed interchangeable by the FDA to be substituted for originally prescribed biologic medicines in the pharmacy setting. SB 598 also included an important provision that the prescribing physician is notified about which biologic therapy was dispensed at a pharmacy so that the specific medication can be noted and tracked in a patient’s health record.

 

Opponents of the bill, which included some labor unions and pharmacists, contended that once the FDA declares a biosimilar interchangeable with the original product, notification of doctors and patients would be unwarranted and unnecessary and only serve to raise doubts about the safety of biosimilars and discourage their use. Supporters of the bill, which included some medical societies and patient advocacy groups, argued that it is essential for doctors to be informed prior to a pharmacist’s switch to a biosimilar in case any problems arise. Even slight differences might, for instance, cause a patient to have an immune reaction to a biosimilar, but not to the original biologic.

 

The defeat of California’s SB 598 was particularly surprising since both houses of legislature had bipartisan support, and awaited only Brown’s John Hancock. But Brown seems to want to wait for the FDA’s regulatory guidelines before enacting legislation, as he stated in his veto letter, “The FDA, which has jurisdiction for approving all drugs, has not yet determined what standards will be required for biosimilars to meet the higher threshold for ‘interchangeability.’ Given this fact, to require physician notification at this point strikes me as premature.”

 

Brown also took issue with the bill’s requirement for pharmacists to send notifications back to prescribers about which drug was dispensed.

 

“This requirement, which on its face looks reasonable, is for some reason highly controversial,” Brown wrote. “Doctors with whom I have spoken would welcome this information. CALPers and other large purchasers warn that the requirement itself would cast doubt on the safety and desirability of more cost-effective alternatives to biologics.”