Print“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.”
Florida legislators have voted to enact a law allowing prescriptions for biologic medicines to be automatically substituted with lower-cost biosimilars, joining other states in easing future market access for the new therapies.
Biosimilars are similar, though not exact copies of original biologic therapies. The industry has argued that because even a miniscule change between a biologic and its biosimilar products might affect patients, the ability to substitute biosimilars for branded products should be restricted.
The Florida law will require records of biosimilar substitution be maintained to support safety monitoring, an element that will be important for building confidence in the therapeutics, but does not mandate a physician notification component, a provision advocated for by the Alliance for Safe Biologic Medicines, a group that represents companies that have the most to lose from biosimilar competition, such as Amgen and Roche’s Genentech.
“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,” says Ralph Neas, president and CEO of the Generic Pharmaceutical Association.
Indiana’s legislature adjourned on April 26 without passing biosimilar legislation, a bill that critics such as the Generic Pharmaceutical Association say would have been restrictive of substitution. Similarly, Colorado's legislature dropped consideration of a biosimilar bill with onerous provisions that had passed the House, effectively killing it for that body’s current session.
To date, according to the Generic Pharmaceutical Association, only North Dakota has passed the type of legislation sought by the Alliance for Safe Biologic Medicines. “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,” says the Association.
In addition to Florida and Indiana, five other states have considered legislation that could make access to biosimilars more cumbersome for patients, including Arizona, Maryland, Mississippi, Nevada and Washington. But none of those states moved to enact laws on the matter. Arkansas has decided to further review the issue of biosimilars. Meanwhile, legislation currently is under consideration in California, Illinois, Massachusetts, Oregon, Pennsylvania and Texas.
Members of the The Lupus Foundation of Florida applauded the legislative action there, saying that “setting up a framework for patients to access biosimilars at pharmacy counters and ensuring the safe substitution and tracking of these highly complex products now—rather than down the road—makes sense.”
May 10, 2013
http://www.burrillreport.com/article-florida_eases_the_way_for_biosimilars.html
