US state biosimilar substitution bill becomes law

  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

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