Florida Blocks Biosimilar Limitations

A bill passed by the Florida legislature would allow pharmacists to substitute biosimilars for brand-named biologics provided that a number of criteria are met.

A bill amending Florida’s existing prescription drug substitution law has the potential to create a pathway for biosimilar product substitution at the pharmacy. The bill passed both houses of the state’s legislature in late April with nearly unanimous support and now must be signed by Governor Rick Scott in order to take effect.

The bill would allow pharmacists to dispense biosimilars in place of branded biologics only if the FDA has determined that the product in question is biosimilar to and interchangeable with the prescribed product and if the prescriber does not express a verbal or written preference for the brand-name product. The pharmacist would also be required to inform the patient of the substitution and to retain a written or electronic record of the substitution. In addition, Florida’s pharmacy board would be directed to maintain a list of FDA-approved interchangeable biologic products on its public website.

Provided Governor Scott signs the bill, it is scheduled to go into effect on July 1, 2013. However, the FDA has not yet approved any biosimilar products.

In a press release, the Generic Pharmaceutical Association (GPhA) stated that Florida was in line with several other states in its action on biosimilar products. The GPhA noted that state legislatures in Indiana and Colorado have either declined to consider or rejected bills that would restrict biosimilar access. Arizona, Mississippi, Nevada, and Washington have also dismissed biosimilar access legislation.

“In the states, nothing is over until the gavel bangs, and the Florida legislature found that the longer they considered these bills, the more they realized the need to encourage, not impede, access to these therapies,” Ralph G. Neas, president and CEO of the GPhA, said in the press release. “Florida spent more than $104 million on biologic medicines in 2011 alone for its state Medicaid program, a number that only will grow. Once the FDA provides full guidance on biosimilar approval and interchangeability, we are confident states like Florida will benefit enormously from these lower-cost, life-saving medications.”

Biosimilar substitution bills are still under consideration in California, Illinois, Massachusetts, Oregon, Pennsylvania, and Texas, the GPhA press release noted.