EU Approves First Biosimilar POHERDY for HER2-positive Breast Cancer
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 29 2026
0mins
Should l Buy OGN?
Source: Newsfilter
- Market Authorization Milestone: Shanghai Henlius Biotech and Organon announced that the European Commission has granted marketing authorization for POHERDY® (pertuzumab), the first biosimilar approved for all indications, marking a significant advancement in treatment access for HER2-positive breast cancer patients, which is expected to greatly enhance patient care options.
- Expanded Clinical Applications: POHERDY is approved for use in combination with trastuzumab and docetaxel for adults with HER2-positive metastatic breast cancer who have not received prior anti-HER2 therapy or chemotherapy, further enriching treatment options and addressing urgent market needs for effective therapies.
- Data-Driven Approval: The approval is based on a comprehensive data package, including structural and functional analytical data, clinical pharmacokinetic data, and comparative clinical studies demonstrating that POHERDY is highly similar to the reference product in terms of safety and efficacy, thereby boosting market confidence.
- Global Commercialization Strategy: The exclusive commercialization agreement between Henlius and Organon covers several biosimilars globally, excluding China, indicating the company's intent to expand in international markets, which is expected to drive future revenue growth.
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Analyst Views on OGN
Wall Street analysts forecast OGN stock price to fall
5 Analyst Rating
0 Buy
1 Hold
4 Sell
Strong Sell
Current: 13.320
Low
5.00
Averages
8.50
High
12.00
Current: 13.320
Low
5.00
Averages
8.50
High
12.00
About OGN
Organon & Co. is a global healthcare company. The Company is engaged in developing and delivering health solutions through a portfolio of prescription therapies and medical devices within women's health, biosimilars and a franchise of established medicines across a range of therapeutic areas. It has a portfolio of approximately 70 medicines and products across a range of therapeutic areas. It has a portfolio of contraception and fertility brands, including Nexplanon, NuvaRing, and Follistim AQ. Its Biosimilars portfolio spans across immunology and oncology treatments. It also has a portfolio of established brands, including brands in cardiovascular, dermatology and non-opioid pain management. It sells these products through various channels, including drug wholesalers and retailers, hospitals, government agencies and managed health care providers, such as pharmacy benefit managers and other institutions.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Merger Impact: In light of the pending merger, Organon will not provide financial guidance or host quarterly earnings calls, a strategy that may exacerbate investor uncertainty regarding the company's future direction and performance.
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