Henlius and Organon Receive the US FDA’s Approval for Poherdy (Biosimilar, Perjeta)
Shots:
- The US FDA has approved Poherdy (420mg/14mL, IV), an interchangeable biosimilar version of Perjeta (pertuzumab) for all indications of the reference product
- Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed similarity & interchangeability in terms of safety, purity, & potency between Poherdy & reference pertuzumab
- In 2022, Henlius granted Organon exclusive global commercialization rights (ex-China) for multiple biosimilars, incl. Poherdy, under a license & supply agreement
Ref: Organon | Image: Henlius & Organon | Press Release
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