A biosimilar is a medicine created to be highly similar to an existing complex drug made from living cells, matching its safety and effectiveness while allowing for small, natural variations. For investors, biosimilars matter because they introduce lower-cost competition when patents end, which can cut prices, shift market share, and change revenue forecasts for companies selling the original drugs, much like a generic version does for simpler chemical medicines.
her2-positivemedical
HER2-positive describes cancer cells that have too many copies of the HER2 gene or make too much of the HER2 protein, which acts like an overactive growth switch that drives tumor growth. For investors, HER2 status matters because it determines whether patients can receive specific, often expensive targeted therapies and diagnostic tests, so trial results, approvals, or competing drugs tied to HER2 can strongly affect drug sales and company value.
neoadjuvantmedical
"Neoadjuvant" describes treatments or interventions that are given before the main or primary procedure, such as surgery or a major decision. It’s like preparing the ground before planting seeds, aiming to improve the final outcome. For investors, understanding neoadjuvant approaches can provide insight into how companies enhance results or effectiveness in their processes or products.
adjuvantmedical
An adjuvant is an ingredient added to a vaccine or other therapy to strengthen or shape the body’s response to the main active component, like a helper that makes the primary ingredient work better or longer. For investors, adjuvants matter because they can change how well a product performs, alter dosing and safety profiles, affect regulatory review, and therefore influence clinical success, market size and competitive advantage.
metastaticmedical
Metastatic describes cancer that has spread from its original spot to other organs or tissues, like weeds moving from one garden bed into several others. For investors, metastatic disease matters because it often requires more complex, long-term treatments, larger clinical trials, and can drive demand for specialized drugs and diagnostics—factors that affect a drug’s development costs, regulatory risk, market size, and potential revenue.
immunogenicitymedical
Immunogenicity is the ability of a substance, such as a vaccine or medication, to provoke an immune response in the body. It matters to investors because high immunogenicity can affect the effectiveness and safety of a product, potentially leading to increased costs or regulatory challenges. Understanding immunogenicity helps assess the long-term viability and market potential of pharmaceutical and biotech investments.
antibody-drug conjugatesmedical
A class of targeted cancer medicines that combine a lab-made antibody (which finds and sticks to specific markers on tumor cells) with a powerful cell-killing drug linked together so the toxic payload is delivered directly to the tumor. Think of it like a guided missile that reduces collateral damage compared with traditional chemotherapy; for investors, success or failure of these drugs drives clinical, regulatory and commercial value and can sharply affect a biotech company’s prospects and stock price.
immune checkpoint inhibitorsmedical
Drugs that release the immune system’s natural “brakes,” allowing immune cells to recognize and attack cancer cells; imagine taking the safety off a guard dog so it can chase intruders. They matter to investors because they can become high-value treatments with large sales potential, but their commercial success depends on clinical trial results, regulatory approval, competition and side-effect management, which all affect a company’s valuation.
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SHANGHAI, China & JERSEY CITY, N.J.--(BUSINESS WIRE)--
Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for POHERDY® (pertuzumab) 420 mg/14 mL injection for intravenous use, the first and only approved biosimilar to PERJETA (pertuzumab) in Europe, for all indications of the reference product.1
“As the first, and currently the only, pertuzumab biosimilar in Europe, the EC’s approval of POHERDY marks an important milestone in expanding access to treatments for patients with certain HER2-positive breast cancers, particularly as breast cancer is the most commonly diagnosed cancer among women in the European Union,” said Joe Azzinaro, Vice President, Global Commercial Lead Biosimilars, at Organon.2,3 “Organon’s growing global portfolio of biosimilars reinforces our ongoing commitment to supporting the sustainability of health care systems while advancing women’s health through access to quality medicines.”3,4
“Building on POHERDY’s FDA approval in the United States as the country’s first pertuzumab biosimilar, this EU approval further expands our growing portfolio of approved biosimilar medicines in markets around the world and is a testament to our strong collaboration with Organon,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. “Guided by our commitment to scientific excellence and product quality, we are working to expand access to additional treatment options for the benefit of patients and the health care system.”
In Europe, POHERDY is indicated in combination with trastuzumab and docetaxel for the treatment of adults with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for metastatic disease. POHERDY is also indicated for use in combination with trastuzumab and chemotherapy as (i) neoadjuvant treatment of adults with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence and (ii) adjuvant treatment of adults with HER2-positive early breast cancer at high risk of recurrence.
POHERDY was approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and comparative clinical studies demonstrating that POHERDY is a biological medicine highly similar to the reference product based on a totality of evidence, including analytical, pharmacokinetic, efficacy, safety, and immunogenicity data (the intrinsic ability of proteins and other biological medicines to cause an immune response).5
In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including POHERDY. The agreement covers exclusive global commercialization rights except for China.6
About POHERDY® (pertuzumab) in the E.U.
Early breast cancer
Poherdy is indicated for use in combination with trastuzumab and chemotherapy in:
the neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence
the adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)
Metastatic breast cancer
Poherdy is indicated for use in combination with trastuzumab and docetaxel in adult patients with HER2-positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease.
Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its “Globalisation 2.0” phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including seven approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and five products approved by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.
Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly® in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in more than 40 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.
Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women’s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.
Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.
This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about POHERDY treatment goals and Organon’s ongoing commitment to supporting the sustainability of health care systems while advancing women’s health through access to quality medicine. Forward-looking statements may be identified by words such as “will,” “plan,” “ongoing,” “commitment to supporting,” “may,” and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K and other SEC filings, available at the SEC’s Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
PERJETA is a trademark registered in the European Union by F. Hoffmann-La Roche AG; Organon is not associated with this trademark owner.
