Henlius and Organon Secure EU Nod for First Pertuzumab Biosimilar
Event summary
- The European Commission approved Henlius and Organon's POHERDY®, the first biosimilar to PERJETA (pertuzumab), for all indications in HER2-positive breast cancer.
- POHERDY is indicated for both early and metastatic breast cancer treatments in combination with trastuzumab and chemotherapy.
- The approval follows a comprehensive data package review demonstrating similarity to the reference product across analytical, pharmacokinetic, efficacy, safety, and immunogenicity metrics.
- Organon holds exclusive global commercialization rights (excluding China) under a 2022 license agreement with Henlius.
The big picture
This approval solidifies Henlius' position as a key player in the biosimilar space, while Organon strengthens its portfolio in women's health and general medicines. The move aligns with broader industry trends toward cost-effective biologic therapies, particularly in oncology, where biosimilars are increasingly disrupting established markets.
What we're watching
- Market Penetration
- How POHERDY's EU approval will impact Henlius and Organon's market share against Roche's PERJETA, particularly in HER2-positive breast cancer treatments.
- Commercial Execution
- Whether Organon can effectively commercialize POHERDY across its global markets, leveraging its existing biosimilar portfolio and distribution network.
- Regulatory Momentum
- The pace at which Henlius advances additional biosimilars through regulatory approvals, following this milestone in Europe.
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