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Corporate Score 55 Bullish

European Commission Approves First Pertuzumab Biosimilar POHERDY

Apr 29, 2026 16:45 UTC
2696.HK, OGN
Medium term

Shanghai Henlius Biotech and Organon have received EU authorization for POHERDY, the first biosimilar version of the breast cancer treatment PERJETA. The approval expands treatment accessibility for HER2-positive breast cancer patients across Europe.

  • First-ever pertuzumab biosimilar approved in the EU
  • Indicated for early and advanced HER2-positive breast cancer
  • Organon manages global commercialization excluding China
  • Strategic partnership established in 2022
  • Aims to improve patient access to oncology care

The European Commission has granted marketing authorization for POHERDY, marking the first time a pertuzumab biosimilar has been approved for use in the European market. The drug is developed by Shanghai Henlius Biotech Inc. and partnered with Organon & Co. POHERDY is designed as a biosimilar to the established therapy PERJETA. It has been cleared for all the same indications as the original product, specifically for the treatment of HER2-positive breast cancer in both early-stage and advanced cases. This approval is expected to significantly lower barriers to treatment in Europe, where breast cancer remains the most frequently diagnosed cancer among women. The commercial rollout is governed by a strategic agreement signed in 2022. Under the terms of the deal, Organon holds the exclusive rights to market and distribute POHERDY worldwide, with the exception of the Chinese market. This arrangement allows both companies to strengthen their respective biosimilar portfolios. Despite the regulatory victory, Shanghai Henlius Biotech (2696.HK) experienced a slight decline in share price on Wednesday, closing at HKD 76.20, a decrease of HKD 1.35 or 1.74 percent on the Hong Kong Stock Exchange.

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