Big Pharma wields big influence in Kentucky for restrictive biosimilars law

The Kentucky State Senate Chamber--Courtesy of Acdixon, Creative Commons CC0 1.0

Big Pharma is on the offensive when it comes to biosimilars. Now, the industry has scored a point in its favor after some Kentucky lawmakers passed a bill that would make it more difficult for patients to get the discounted copycats.

By a 36-to-1 vote, the Kentucky Senate said that pharmacists should notify prescribing physicians within 5 days of any switches from branded drugs to biosimilars, the Kentucky Center for Investigative Reporting reports. The law would only apply to biosimilars that meet federal "interchangeability," guidelines, or rules that allow biosimilars to be swapped in as long as they have the same medical effects as the original drug. Now the bill is going before the Kentucky House of Representatives and could potentially move to the Kentucky Governor after that for a final vote.

Pharma can pat itself on the back for the recent development. The industry had a record number of lobbyists registered in Frankfort, KY, to push for the bill's passage, KYCIR points out. There were more than 80 lobbyists in the state last year, and the industry spent upward of $800,000 to get the law passed. For comparison's sake, in 2013 there were only about 60 pharma lobbyists in Kentucky and the industry spent less than $600,000 on lobbying efforts.

Still, not everyone is celebrating the bill's passage. Pharmacists are opposed to the change, with the Kentucky Pharmacists Association (KPhA) saying that the law would force doctors to prescribe more costly meds. "Prescriber notification requirements have shown to increase costs for the healthcare system overall because they result in more brand dispensing," KPhA Executive Director Bob McFalls told KYCIR.

Regulators have not approved any "interchangeables," or cheaper biosimilar substitutions. Novartis ($NVS) is the only company with a biosimilar on the market with its copy of Amgen's ($AMGN) Neupogen.

But pharma is still bracing for the biosimilar onslaught as companies push their candidates through development. And some biosimilar manufacturers are doing everything they can to make sure that their cheap knockoffs have a fighting chance.

Last month, Novartis' Sandoz unit asked the Supreme Court to review an appeals court ruling that forces a biosimilar developer to give a branded drugmaker a 180-day notice before launching its product. If the lower court's decision is allowed to stand, it "will delay the availability of all biosimilars for 180 days more than Congress intended--even if the sponsor has no valid patent claims and even if the sponsor already has had the opportunity to pursue any valid claims," the company said at the time.

- read the KYCIR story

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