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FDA Approves First Biosimilar

In 2010, Congress enacted the Biologics Price Competition and Innovation Act (BPCIA), creating a regulatory pathway for the Food and Drug Administration (FDA) to approve biosimilars, which are copies of brand name biologics. Unlike "traditional" drugs, biologics are large, complex molecules that are more difficult to copy because small manufacturing changes can have meaningful effects on the final product.

Implementation of the BPCIA has been hotly contested in the five years since enactment, but FDA has yet to issue formal regulations. Instead, the agency released four draft guidances that left many key implementation questions unanswered. Even so, on March 6, 2015, FDA approved the first biosimilar: Zarxio, a copy of Neupogen (filgrastim). Zarxio received approval for all five indications for which Neupogen is approved, in the process answering a key implementation question: whether a biosimilar can extrapolate biosimilarity shown in one indication to all of the brand product's other indications.

Regardless of federal policy positions, the circumstances in which a biosimilar may be substituted are likely to be decided at the state level. Dozens of states have considered or currently are considering biosimilar legislation. For physicians, a critical component of such legislation is whether a pharmacist must notify the physician when a substitution has been made. Such notification usually does not occur with traditional generic substitution, but the complexity of biologics may warrant a different approach.

Indeed, most patient and physician groups believe that proactive notification by the pharmacist within a reasonable time of the substitution is critical for patient safety and tracking purposes. Through the Alliance of Specialty Medicine, ASPS has weighed in to support notification within a reasonable time in many state legislatures. Thus far, most states have required notification as supported by ASPS and other physician groups.