Organon, Shanghai Henlius Biotech Says FDA Clears Poherdy as Pertuzumab Biosimilar

MT Newswires Live

Nov 17

Organon (OGN) and Shanghai Henlius Biotech said Monday that the US Food and Drug Administration has approved the biologics license application for Poherdy as an "interchangeable biosimilar" to Perjeta, also known as pertuzumab.

The companies said Poherdy is indicated for use in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic breast cancer, and in combination with trastuzumab and chemotherapy as a neoadjuvant treatment for adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer.

Organon has a 2022 license deal with Shanghai Henlius Biotech, covering exclusive commercialization rights to Poherdy and other biosimilars, according to the statement.

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