The FDA’s verdict on Poherdy comes amid Perjeta creator Genentech’s patent infringement lawsuit against Organon and Shanghai Henlius Biotech.
Shanghai Henlius Biotech and Organon have obtained US approval for their Perjeta biosimilar, Poherdy (pertuzumab-dpzb).
This makes it the first interchangeable Perjeta biosimilar to gain approval from the US Food and Drug Administration (FDA).
Like its branded counterpart, Poherdy will be available to patients with human epidermal growth factor receptor 2 (HER2)-positive, metastatic breast cancer. It will also be indicated for use in combination with trastuzumab and chemotherapy in both the adjuvant and neoadjuvant settings.
This follows a comprehensive review from the FDA, which found that Poherdy is “highly similar to Perjeta”, with no clinically meaningful differences in efficacy and safety observed between the two products.
The agency made this call based on the results of a pharmacokinetic (PK) study in healthy adults, as well as a phase 3 trial in the neoadjuvant HER2-positive, HR-negative breast cancer setting.
Poherdy’s approval comes after the FDA debuted plans to simplify the interchangeable biosimilar development process, which is set to help patients and prescribers identify
low-cost brand alternatives more easily.
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