Henlius and Organon Secure First EU Approval for Pertuzumab Biosimilar
Event summary
- The European Commission approved Henlius and Organon’s POHERDY®, the first biosimilar to PERJETA (pertuzumab), for all indications of the reference product in Europe.
- POHERDY is indicated for HER2-positive breast cancer treatments, including metastatic, neoadjuvant, and adjuvant settings.
- The approval follows a comprehensive data package review, demonstrating POHERDY’s similarity to PERJETA based on analytical, pharmacokinetic, efficacy, safety, and immunogenicity data.
- Henlius and Organon entered into a license and supply agreement in 2022, granting Organon exclusive commercialization rights for several biosimilars, including POHERDY.
The big picture
This approval marks a significant step in the biosimilar landscape, particularly for HER2-positive breast cancer treatments. The collaboration between Henlius and Organon underscores the strategic importance of biosimilars in expanding access to affordable cancer therapies. The European market’s acceptance of POHERDY could set a precedent for future biosimilar approvals and commercialization strategies.
What we're watching
- Market Penetration
- How POHERDY will compete with PERJETA in the European market, given its first-mover advantage as a biosimilar.
- Commercial Execution
- Whether Organon can effectively commercialize POHERDY and other biosimilars under its license agreement with Henlius.
- Regulatory Expansion
- The pace at which Henlius and Organon seek approvals for POHERDY in other major markets beyond Europe.
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