On 21 March 2013, the US State of Virginia signed into law a legislation allowing for the substitution of biosimilars, but with many restrictions, making it the first US state to introduce such legislation. Brand-name biologicals manufacturers have praised the law as putting patients first, but the generics industry has accused it of pre-empting FDA guidance.The new law will give physicians the authority to specify ‘do not substitute’ and for patients to insist on getting the brand-name drug. It also enables these rights to override any policy from FDA that would allow for automatic substitution of a biosimilar with its reference product.
The law requires any pharmacist who dispenses an interchangeable biosimilar to inform the patient prior to dispensing the biosimilar, provide notification of the substitution to the prescribing physician, and record the brand name or the product name and the name of the manufacturer of the biosimilar on the dispensing record and the prescription label [1].
The Biotechnology Industry Organization (BIO), which represents originator biotechnology companies, commended the bill, which aligns with all five of the organization’s principles on biological substitution. BIO believes that the legislation will protect patient safety and should be used as a model for all 50 US states.
However, the generics industry disagrees. Mr Ralph G Neas, President and CEO of the Generic Pharmaceutical Association (GPhA), stated that ‘while well intentioned’ the legislation ‘is pre-emptive, and carries burdensome administrative “red tape” that threatens the positive impact biosimilars will have in Virginia’. GPhA adds that ‘the time to pass this legislation is after FDA guidance has been issued; and that laws put in place should not create barriers between patients and needed medicines.’
It’s not all bad news for biosimilars manufacturers though. The legislation passed in Virginia includes a two-year ‘sunset’ clause. This clause means that the bill will expire in 2015, which is likely to be before a biosimilar is approved and becomes available in the US. GPhA believes that ‘this provision reflects the need to fully understand FDA guidance before instituting long-term regulations affecting biosimilar use’. GPhA is therefore urging state legislators ‘to reject biosimilar substitution legislation that pre-empts the FDA’ and wait until FDA has finalized its guidance on substitution of biosimilars before making any decisions.
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Reference
1. GaBI Online – Generics and Biosimilars Initiative. Biotech firms try to limit biosimilar substitution in US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Mar 29]. Available from: www.gabionline.net/Biosimilars/News/Biotech-firms-try-to-limit-biosimilar-substitution-in-US
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Source: BIO, GPhA
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