GPhA supports the new legislation in Florida about biosimilars

May 28, 2013 2:04 PM


At the beginning of this month, Florida joined several states, in refusing to enact legislation that would create barriers between patients and newer, lower-cost versions of biologic medicines known as biosimilars.

The Florida legislature voted to approve a bill on biosimilars that follows current substitution practices for prescription medicines, rejecting efforts by Amgen and Genentech to limit future access to these therapies once they reach the market.

“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. We applaud state Senator Denise Grimsley, state Representative Matt Hudson, and other Florida legislators who did the right thing for patients across their state: they eliminated language in this legislation that would have a chilling effect on the use of biosimilar medicines,” said Ralph G. Neas, President and CEO of the Generic Pharmaceutical Association (GPhA). “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 that states like Florida will benefit enormously from these lower-cost, life-saving medicines.”

As introduced, the Florida bill included problematic provisions such as limitations on substitution, additional paperwork requirements, and mandates for notifying physicians beyond current law. Last Friday, the legislature adjourned, so the bill now heads to the Florida Governor to sign into law with none of those provisions attached.

In addition, the Indiana legislature adjourned on April 26th without passing restrictive biosimilar legislation. Similarly, the Colorado legislature declined to further consider a biosimilar bill with onerous provisions that had passed the House, effectively killing it for this session, which ends in that state.

To date, North Dakota is the only state that has passed intact the type of legislation sought by Amgen and Genentech. Virginia and Utah have passed such laws, but they are constrained by a sunset clause, which most experts believe will render the restrictive sections moot before biosimilars come to market.

In addition to Florida and Indiana, five other states considered legislation that undermines access to biosimilars this session and decided to forgo it altogether: Arizona, Maryland, Mississippi, Nevada and Washington state. Arkansas decided biosimilar implementation legislation warrants further review, and referred it to a study committee. Legislation currently is under consideration in California, Illinois, Massachusetts, Oregon, Pennsylvania and Texas.

In sum, of the eleven states that have considered burdensome measures that restrict biosimilar access, only one has passed the version supported by Amgen and Genentech.


Source: GPhA press release

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