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California Considers Biosimilar Drug Regulations

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Though biosimilar drugs are not yet sold, marketed, or FDA-approved, they are already the topic of regulation in state legislatures. A bill that would allow pharmacists to substitute cheaper, FDA-approved biosimilar drugs for their brand name counterparts passed by wide margins in the California Assembly and Senate, and now needs Governor Jerry Brown’s signature. According to the bill, prescribers can indicate “do not subscribe” to prevent pharmacists from dispensing substitutes. Otherwise, pharmacists would be required to notify prescribers of any biosimilar or biological drug selections within five business days.

Other states have already passed or considered similar legislation regulating access to biosimilar drugs. For a map from the Generic Pharmaceutical Association, click here.


Bill Text


One thought on “California Considers Biosimilar Drug Regulations

  1. Pingback: California Governor Jerry Brown Vetoes Biosimilar Drugs Bill | AcuPartD

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