Virginia has become the first US state to introduce legislation governing the substitution of biosimilar drugs for prescribed biologics. Brand-name drugmakers have welcomed the law as "a model" for all US states, but the generics industry has attacked it for pre-empting FDA guidance.
Virginia's new law states that it "permits pharmacists to dispense a biosimilar that has been licensed by the US Food and Drug Administration [FDA] as interchangeable with a prescribed biological product unless the prescriber indicates such substitution is not authorised or the patient insists on dispensing of the prescribed biological product."It "requires any pharmacist who dispenses an interchangeable biosimilar to inform the patient prior to dispensing the biosimilar and record the brand name or the product name and name of the manufacturer of the biosimilar on the record of dispensing and the prescription label."
The restrictions included in Virginia's new law - which was signed by Governor Bob McDonnell late last week and takes effect even though the FDA has yet to approve its first biosimilar or indeed announce its guidance - have been welcomed by the Biotechnology Industry Organisation (BIO), which points out that it aligns with all five of the industry group's principles on biologic substitution. These state that: - substitution should occur only when the FDA has designated a biologic product as interchangeable; - the prescribing physician should be able to prevent substitution; - the prescribing physician should be notified of the substitution; - the patient, or the patient's authorised representative, should, at a minimum, be notified of the substitution; and - the pharmacist and the physician should keep records of the substitution.
The Virginia legislation "properly preserves the physician-patient relationship, protects patient access to accurate prescription information, maintains incentives for innovation and promotes a competitive market for biologic therapies," says BIO. The law "is a model for legislation necessary in all 50 states to address this cutting-edge technology," the group adds.
However, according to the Generic Pharmaceutical Association (GPhA), the law is well-intentioned but is also "pre-emptive, and carries burdensome administrative red tape that threatens the positive impact biosimilars will have in Virginia."GPhA believes 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," the Association warns.
But while GPhA says it "strenuously objects to any bill that includes barriers to biosimilar use that pre-empts FDA guidance," it does welcome the fact that Virginia's legislation is limited by a two-year "sunset" clause. The bill is designed to expire on July 1, 2015, and until that date, pharmacists will be required to "provide notification of the substitution to the prescriber and provide retail cost information for both the prescribed biological product and the interchangeable biosimilar to the patient."The bill's expiry in 2015 is likely to occur before the first biosimilar is approved and made available in the US, and the inclusion of this sunset clause "reflects the need to fully understand FDA guidance before instituting long-term regulations affecting biosimilar use," says BIO.
Two other US states have now passed legislation relating to biosimilar substitution, although these have yet to be signed into law. Bill are also pending in eight further state legislatures and have failed in five others. Last month, biotechnology companies were condemned by consumer groups and others for alleged vigorous lobbying of state legislators with the aim of restricting access to biosimilars.