Henlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the US
Organon & Co. (OGN)
Company Research
Source: PR Newswire
SHANGHAI and JERSEY CITY, N.J., Nov. 17, 2025 /PRNewswire/ -- Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for POHERDY® (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use, an interchangeable biosimilar to PERJETA (pertuzumab), for all indications of the reference product.[1] POHERDY is the first and only approved pertuzumab biosimilar in the US, representing an important milestone in expanding access to quality and potentially more affordable biologic therapies for patients with certain HER2-positive breast cancers.[2]"Expanding access to treatments for diseases that disproportionately impact women, including breast cancer, the most common cancer among women in the US excluding skin cancer, is at the core of our mission," said Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon.[3] "Not only is POHERDY the first ap
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- Henlius and Organon Announce US FDA Approval of POHERDY® (pertuzumab-dpzb), the First PERJETA (pertuzumab) Biosimilar in the USBusiness Wire
- Organon Investigation Initiated By Former Louisiana Attorney General: Kahn Swick & Foti, LLC Investigates Claims On Behalf of Investors of Organon & Co. - OGNBusiness Wire
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OGN
Earnings
- 11/10/25 - Beat
OGN
Sec Filings
- 11/17/25 - Form 4
- 11/17/25 - Form 4
- 11/12/25 - Form 4
- OGN's page on the SEC website