Shanghai Henlius Biotech and Organon announced that the European Commission has granted marketing authorization for POHERDY (pertuzumab) 420 mg/14 mL injection for intravenous use as the first and currently only approved biosimilar to Perjeta (pertuzumab) in Europe, for all indications of the reference product. In Europe, POHERDY is indicated in combination with trastuzumab and docetaxel for the treatment of adults with HER2‑positive metastatic or locally recurrent unresectable breast cancer who have not received prior anti‑HER2 therapy or chemotherapy for metastatic disease.
POHERDY is also indicated in combination with trastuzumab and chemotherapy as neoadjuvant treatment of adults with HER2‑positive, locally advanced, inflammatory, or early‑stage breast cancer at high risk of recurrence, and as adjuvant treatment of adults with HER2‑positive early breast cancer at high risk of recurrence. The EC approval was based on a comprehensive data package including structural and functional analytical data, clinical pharmacokinetic data, and comparative clinical studies, which together showed that POHERDY is highly similar to the reference product in terms of analytical characteristics, pharmacokinetics, efficacy, safety, and immunogenicity.
The companies noted that POHERDY had previously received approval from the U.S. Food and Drug Administration as the first pertuzumab biosimilar in the United States. In 2022, Henlius entered into a license and supply agreement granting Organon exclusive global commercialization rights to several biosimilars, including POHERDY, with the exception of China, where Henlius retains rights.
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