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July 26 — Retail pharmacists in Pennsylvania will be able to swap out brand name biologics with interchangeable biological products beginning in September, under a measure signed into law by Gov. Tom Wolf (D)July 20.
Senate Bill 514, now 2016 Act 95, amends the state's Generic Equivalent Drug Law (Act 259 of 1976) to allow substitution of an interchangeable biological product for a brand name biologic.
The new law was necessary because laws applicable to generics cannot be applied uniformly to biosimilar products, the bill's sponsor, Patricia H. Vance (R), wrote in a memo accompanying the bill. Previously, Pennsylvania's generics law permitted substitution of generic drugs for a brand name drugs, unless the physician indicated the brand is medically necessary. Yet when dealing with biologics, such a substitution may not always be the best course of treatment, Vance wrote. The new legislation permits substitution of biologics only when the prescribed product and the biosimilar product have been approved by the Food and Drug Administration as being interchangeable.
The biotechnology industry praised the law's passage.
In a statement July 22, the Biotechnology Innovation Organization, the world's largest trade association representing biotechnology companies, said the legislation was “critical” to creating a pathway for the substitution of interchangeable biologic medicines, and that policies outlined in the bill aligned with the group's principles on biologic substitution.
“We’re pleased to see Pennsylvania adopting policies that not only support a growing industry in our state, but more important, facilitate patient access to lower-cost, interchangeable therapies once approved as such by the FDA,” said Pennsylvania Bio President and Chief Executive Officer Christopher Molineaux. “This important bill will provide patients more opportunities to address their medical needs, particularly severely ill patients who rely on complex biological treatments.”
The pharmacist must notify the prescriber within 72 hours of dispensing the first substitution, according to the most recent online version of the legislation.
The measure passed the House and Senate unanimously July 11 and was signed by the governor July 20. It takes effect in 60 days.
A 2010 federal law created a pathway for the FDA to approve biosimilar versions and interchangeable versions of biologic drugs.
Currently, the FDA has approved only two biosimilar products: Sandoz's Zarxio, a generic version of Amgen's Neupogen, and Pfizer's and Celltrion's Inflectra, a biosimilar of Johnson & Johnson's arthritis treatment Remicade. No interchangeable biologics have been approved.
Pennsylvania is the most recent of a number of states to enact legislation targeting biologic drug substitution. New Jersey enacted similar legislation in November 2015 that required pharmacists to notify prescribers when dispensing an interchangeable biologic (9 LSLR 1295, 11/13/15).
Thirteen states and Puerto Rico have enacted similar measures, according to the Generic Pharmaceutical Association.
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Pennsylvania 2016 Act 95 is at http://src.bna.com/g7C.
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