Florida legislature passes biosimilar substitution bill

NEW YORK — Florida's state legislature approved a bill last week that will allow pharmacists to substitute biosimilars for brand name biotech drugs.

The bill, which was approved last Tuesday and is scheduled to take effect on July 1, institutes requirements for pharmacists to substitute biosimilars when they are determined to be biosimilar to and interchangeable with the brand name product, while also requiring the state board of pharmacy to maintain a current list of interchangeable products.

The bill is the latest episode in an ongoing battle between the generic drug industry and biotech companies. Several states have considered legislation that would allow physicians to side-step pharmacists who would otherwise substitute a biosimilar drug while requiring the pharmacist to notify the physician and patient when substitution had taken place; Virginia Gov. Bob McDonnell signed such a bill into law earlier this year, but it contained a sunset provision, meaning that it would expire after two years.

The Patient Protection and Affordable Care Act of 2010 included an amendment creating an abbreviated regulatory approval pathway for biosimilars, but the Food and Drug Administration still has to create regulations for them before it can approve biosimilars under such a pathway; for the time being, some drug makers such as Teva Pharmaceutical Industries have sought approval for biosimilars under the pathway used for brand-name biotech drugs.

The generics industry sees such bills as an attempt to limit access to biosimilars, touted as cheaper alternatives to brand name biotech drugs, which can cost tens of thousands or even hundreds of thousands of dollars per year. Meanwhile, biotech companies say that because of the unique properties of biotech drugs, it is difficult or impossible to create an exact replica of one, as is the case with generic pharmaceutical drugs. As such, they say, there is a risk that biosimilars may differ from their brand-name counterparts in terms of safety and efficacy, a claim that generic drug companies reject.

The Generic Pharmaceutical Association, a trade group for the generic drug industry, heralded the Florida bill's passage.

"Florida spent more than $104 million on biologic medicines in 2011 alone for its state Medicaid program, a number that only will grow," GPhA president and CEO Ralph Neas said. "Once the FDA approves full guidance on biosimilar approval and interchangeability, we are confident that states like Florida will benefit enormously fro these lower-cost, life-saving medicines."