Shanghai Henlius Biotech and Organon Reports EMA’s Validation of HLX11 (Biosimilar, Perjeta)
Shots:
- The EMA has validated MAA of HLX11, a biosimilar version of Perjeta (pertuzumab) for all indications of the reference product
- Submission was supported by P-III trial evaluating HLX11 vs Perjeta as neoadj. therapy in HER2+/HR-, early stage or locally advanced breast cancer as part of complete treatment regimen. Study met its 1EP of total pathological complete response (tpCR) per IRC & demonstrated comparable 2EPs
- Additionally, Henlius granted Organon exclusive global commercialization rights (excl. China) for 2 biosimilar candidates, incl. HLX11, as per a license & supply agreement signed in 2022
Ref: Businesswire | Image: Henlius & Organon
Related News:- Organon and Shanghai Henlius Biotech Provides Update on P-III Trial of HLX11 (Biosimilar, Perjeta)
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Ridhi is an avid secondary researcher who follows trends in the biopharmaceutical and healthcare sectors to curate engaging content for the global audience. She works as a news editor at PharmaShots and loves to read books and explore new destinations.
