The FDA has approved Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Perjeta (pertuzumab).
Poherdy, as approved, is indicated for use in adults with HER2-positive breast cancer, including metastatic cases, early-stage breast cancer at high risk of recurrence, and as a neoadjuvant treatment for locally advanced, inflammatory or early-stage disease. It may be used in combination with trastuzumab and chemotherapy, according to a Nov. 13 news release.
The FDA’s approval comes on the heels of an Oct. 29 draft guidance aimed at simplifying biosimilar drug development. The revised guidelines eliminate routine requirements for comparative efficacy studies and allow developers to rely more heavily on analytical testing instead of clinical trials. The guidance also aims to streamline how biosimilars gain interchangeable status with brand-name biologics.
Poherdy’s approval followed a comprehensive review of structural, functional and clinical data, including a pharmacokinetic study in healthy adults and a neoadjuvant study in patients with early HER2-positive, HR-negative breast cancer, according to the release.
As an interchangeable biosimilar, Poherdy may be substituted for Perjeta at the pharmacy level, depending on state law.
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