{"id":955748,"date":"2026-04-29T05:33:00","date_gmt":"2026-04-29T09:33:00","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\/"},"modified":"2026-04-29T05:33:00","modified_gmt":"2026-04-29T09:33:00","slug":"european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\/","title":{"rendered":"European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe"},"content":{"rendered":"<p>        <!--.bwalignc { text-align: center; list-style-position: inside }\n.bwalignl { text-align: left }\n.bwblockalignl { margin-left: 0px; margin-right: auto }\n.bwcellpmargin { margin-bottom: 0px; margin-top: 0px }\n.bwlistdisc { list-style-type: disc }\n.bwpadl0 { padding-left: 0px }\n.bwtablemarginb { margin-bottom: 10px }\n.bwtopsingle { border-top: solid black 1pt }\n.bwuline { text-decoration: underline }\n.bwvertalignt { vertical-align: top }\n.bwwidth1 { width: 1% }\n.bwwidth100 { width: 100% }\n.bwwidth2 { width: 2% }\n.bwwidth27 { width: 27% }\n.bwwidth70 { width: 70% }body {font:normal small Arial,Helvetica,sans-serif;color:#000;background-color:#fff;padding:24px;margin:0;} a img {border:0;} h3 {font-size:medium;color:#000;margin:0 0 1em 0; text-align:center;}-->  <\/p>\n<p class=\"bwalignc\"><b>European Commission (EC) Approves Henlius and Organon\u2019s POHERDY<sup>\u00ae<\/sup> (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe<\/b><\/p>\n<p>SHANGHAI, China &amp; JERSEY CITY, N.J.&#8211;(<a href=\"http:\/\/www.businesswire.com\">BUSINESS WIRE<\/a>)&#8211;<br \/>\nShanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for POHERDY<sup>\u00ae<\/sup> (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.<sup>1<\/sup><\/p>\n<p id=\"news-body-cta\">This press release features multimedia. View the full release here: <a href=\"https:\/\/www.businesswire.com\/news\/home\/20260429686426\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20260429686426\/en\/<\/a><\/p>\n<p>\n\u201cAs the first, and currently the only, pertuzumab biosimilar in Europe, the EC\u2019s 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,\u201d said Joe Azzinaro, Vice President, Global Commercial Lead Biosimilars, at Organon.<sup>2,3 <\/sup>\u201cOrganon\u2019s growing global portfolio of biosimilars reinforces our ongoing commitment to supporting the sustainability of health care systems while advancing women\u2019s health through access to quality medicines.\u201d<sup>3,4<\/sup><\/p>\n<p>\n\u201cBuilding on POHERDY\u2019s FDA approval in the United States as the country\u2019s 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,\u201d said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. \u201cGuided 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.\u201d<\/p>\n<p>\nIn 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.<\/p>\n<p>\nPOHERDY 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).<sup>5<\/sup><\/p>\n<p>\nIn 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.<sup>6<\/sup><\/p>\n<p><b><span class=\"bwuline\">About POHERDY<sup>\u00ae <\/sup>(pertuzumab) in the E.U.<br \/>\n<\/span><\/b><br \/><span class=\"bwuline\">Early breast cancer<br \/>\n<\/span><br \/>Poherdy is indicated for use in combination with trastuzumab and chemotherapy in:<\/p>\n<ul class=\"bwlistdisc\">\n<li>\nthe neoadjuvant treatment of adult patients with HER2-positive, locally advanced, inflammatory, or early stage breast cancer at high risk of recurrence<\/p>\n<\/li>\n<li>\nthe adjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence (see section 5.1)<\/p>\n<\/li>\n<\/ul>\n<p><span class=\"bwuline\">Metastatic breast cancer<br \/>\n<\/span><br \/>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.<\/p>\n<p>\nFor more information please visit: <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fmedicines%2Fhuman%2FEPAR%2Fpoherdy&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=Poherdy+%7C+European+Medicines+Agency+%28EMA%29&amp;index=1&amp;md5=7bc004ea6bd2c8a9ced9bdf913d313a3\">Poherdy | European Medicines Agency (EMA)<\/a><\/p>\n<p><b><span class=\"bwuline\">About Henlius<\/span><\/b><\/p>\n<p>\nShanghai 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&amp;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 \u201cGlobalisation 2.0\u201d 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&amp;D capabilities, quality systems, and manufacturing standards.<\/p>\n<p>\nDriven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&amp;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\u2019 core product, serplulimab (trade name: Hetronifly<sup>\u00ae<\/sup> in Europe), is the world\u2019s first anti\u2013PD-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\u2014including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22\u2014are 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.<\/p>\n<p>\nTo learn more about Henlius, visit <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.henlius.com%2Fen%2Findex.html&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.henlius.com%2Fen%2Findex.html&amp;index=2&amp;md5=52d98f2388a9b662ce9dbace24c97913\">https:\/\/www.henlius.com\/en\/index.html<\/a> and connect with us on LinkedIn at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fhenlius%2F&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fhenlius%2F&amp;index=3&amp;md5=5e97b7b93e28d433eb12d8ac9c9fd55e\">https:\/\/www.linkedin.com\/company\/henlius\/<\/a>.<\/p>\n<p><b><span class=\"bwuline\">About Organon<\/span><\/b><\/p>\n<p>\nOrganon (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\u2019s 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.<\/p>\n<p>\nHeadquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fnam04.safelinks.protection.outlook.com%2F%3Furl%3Dhttp%253A%252F%252Fwww.organon.com%252F%26data%3D05%257C02%257Ckarissa.peer%2540organon.com%257Cd2971f9c50ef4c360aae08ddb38a9b03%257C484a70d1caaf4a03a4771cbe688304af%257C0%257C0%257C638864130080245634%257CUnknown%257CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%253D%253D%257C0%257C%257C%257C%26sdata%3DfWrU5Mp1uUpvZmomVYKb%252BKQEi89vBlbCIaun1VSJrrM%253D%26reserved%3D0&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=www.organon.com&amp;index=4&amp;md5=114fff4be21ba56fa1fa77edba10a348\">www.organon.com<\/a> and follow us on <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Forganon%2F&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=LinkedIn&amp;index=5&amp;md5=d17c85474f998d7acf383685b8cc765e\">LinkedIn<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.instagram.com%2Forganonllc%2F&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=Instagram&amp;index=6&amp;md5=148bae53de4fac93fe5ead2537310fb9\">Instagram<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fx.com%2FOrganonLLC&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=X&amp;index=7&amp;md5=ed6dcc88f00709ba7ceb3d48c2a1e76e\">X<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.youtube.com%2Fchannel%2FUCFXZcWljXuEhDkMCmZZ4Yzw&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=YouTube&amp;index=8&amp;md5=ff1cbe98688d766145dbc0a1af442f6a\">YouTube<\/a>, <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.tiktok.com%2F%40organon_llc&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=TikTok&amp;index=9&amp;md5=bc66132d5abeaea8700b99536079d5aa\">TikTok<\/a> and <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.facebook.com%2FOrganonLLC%2F&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=Facebook&amp;index=10&amp;md5=3c100be10ae172547571ef1de8c0b896\">Facebook<\/a>.<\/p>\n<p><b><span class=\"bwuline\">Cautionary Note Regarding Forward-Looking Statements<\/span><\/b><\/p>\n<p>\nThis press release includes \u201cforward-looking statements\u201d 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\u2019s ongoing commitment to supporting the sustainability of health care systems while advancing women\u2019s health through access to quality medicine. Forward-looking statements may be identified by words such as \u201cwill,\u201d \u201cplan,\u201d \u201congoing,\u201d \u201ccommitment to supporting,\u201d \u201cmay,\u201d and words of similar meaning. These statements are based upon the current beliefs and expectations of Organon\u2019s 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\u2019s filings with the SEC, including Organon\u2019s most recent Annual Report on Form 10-K and other SEC filings, available at the SEC\u2019s Internet site (<a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.sec.gov%2F&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=www.sec.gov&amp;index=11&amp;md5=bec03f3c7d3d105907358baf6e722b1a\">www.sec.gov<\/a>). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.<\/p>\n<p>\nPERJETA is a trademark registered in the European Union by F. Hoffmann-La Roche AG; Organon is not associated with this trademark owner.<\/p>\n<table cellspacing=\"0\" class=\"bwtablemarginb bwblockalignl bwwidth100\">\n<tr>\n<td class=\"bwpadl0 bwwidth2 bwvertalignt bwtopsingle\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\n\u00a0<\/p>\n<\/td>\n<td class=\"bwpadl0 bwwidth1 bwtopsingle\" rowspan=\"1\" colspan=\"1\" \/>\n<td class=\"bwpadl0 bwwidth27 bwtopsingle\" rowspan=\"1\" colspan=\"1\" \/>\n<td class=\"bwpadl0 bwwidth70\" rowspan=\"1\" colspan=\"1\" \/><\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0 bwwidth2\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\"><sup>1.<\/sup><\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0 bwwidth1\" rowspan=\"1\" colspan=\"1\" \/>\n<td colspan=\"2\" class=\"bwvertalignt bwpadl0\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\nPERJETA. Product Information. Genentech, Inc.; 2025.<\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0 bwwidth2\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\"><sup>2.<\/sup><\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0 bwwidth1\" rowspan=\"1\" colspan=\"1\" \/>\n<td colspan=\"2\" class=\"bwvertalignt bwpadl0\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\nBreast cancer in the EU. European Commission, Joint Research Centre. October 2023. Accessed April 14, 2026. <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fecis.jrc.ec.europa.eu%2Fsites%2Fdefault%2Ffiles%2F2024-01%2Fjrc_Breast_cancer_2022_Oct_2023.pdf&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=https%3A%2F%2Fecis.jrc.ec.europa.eu%2Fsites%2Fdefault%2Ffiles%2F2024-01%2Fjrc_Breast_cancer_2022_Oct_2023.pdf&amp;index=12&amp;md5=5d77204ff1b6e0ec15fa3f6939e37efd\">https:\/\/ecis.jrc.ec.europa.eu\/sites\/default\/files\/2024-01\/jrc_Breast_cancer_2022_Oct_2023.pdf<\/a><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0 bwwidth2\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\"><sup>3.<\/sup><\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0 bwwidth1\" rowspan=\"1\" colspan=\"1\" \/>\n<td colspan=\"2\" class=\"bwvertalignt bwpadl0\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\nEuropean Medicines Agency and the European Commission. Biosimilars in the EU: information guide for healthcare professionals. European Medicines<sup \/>Agency (EMA). Last Updated October 29, 2019. Accessed April 14, 2026. <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Fleaflet%2Fbiosimilars-eu-information-guide-healthcare-professionals_en.pdf&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Fleaflet%2Fbiosimilars-eu-information-guide-healthcare-professionals_en.pdf&amp;index=13&amp;md5=11bef0bd763b23651aef405aa4749431\">https:\/\/www.ema.europa.eu\/en\/documents\/leaflet\/biosimilars-eu-information-guide-healthcare-professionals_en.pdf<\/a><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0 bwwidth2\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\"><sup>4.<\/sup><\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0 bwwidth1\" rowspan=\"1\" colspan=\"1\" \/>\n<td colspan=\"2\" class=\"bwvertalignt bwpadl0\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\nTroein P, Newton M, Stoddart K, Travaglio M, Arias A. The impact of biosimilar competition in Europe. IQVIA; January 2025. Accessed April 14, 2026. <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.iqvia.com%2F-%2Fmedia%2Fiqvia%2Fpdfs%2Flibrary%2Fwhite-papers%2Fthe-impact-of-biosimilar-competition-in-europe-2024.pdf&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.iqvia.com%2F-%2Fmedia%2Fiqvia%2Fpdfs%2Flibrary%2Fwhite-papers%2Fthe-impact-of-biosimilar-competition-in-europe-2024.pdf&amp;index=14&amp;md5=d1bd5f23b7e0c3444cec4aaac6e138ce\">https:\/\/www.iqvia.com\/-\/media\/iqvia\/pdfs\/library\/white-papers\/the-impact-of-biosimilar-competition-in-europe-2024.pdf<\/a><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0 bwwidth2\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\"><sup>5.<\/sup><\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0 bwwidth1\" rowspan=\"1\" colspan=\"1\" \/>\n<td colspan=\"2\" class=\"bwvertalignt bwpadl0\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\nBiosimilar medicines: overview. European Medicines Agency (EMA). April 2, 2025. Accessed April 14, 2026. <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fhuman-regulatory-overview%2Fbiosimilar-medicines-overview&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fhuman-regulatory-overview%2Fbiosimilar-medicines-overview&amp;index=15&amp;md5=de920d632e7eeed928a8ab5f13d8ba6d\">https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/biosimilar-medicines-overview<\/a><\/p>\n<\/td>\n<\/tr>\n<tr>\n<td class=\"bwvertalignt bwpadl0 bwwidth2\" rowspan=\"1\" colspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\"><sup>6.<\/sup><\/p>\n<\/td>\n<td class=\"bwvertalignt bwpadl0 bwwidth1\" rowspan=\"1\" colspan=\"1\" \/>\n<td colspan=\"2\" class=\"bwvertalignt bwpadl0\" rowspan=\"1\">\n<p class=\"bwcellpmargin bwalignl\">\nOrganon Enters into Global License Agreement to Commercialize Henlius\u2019 Investigational Perjeta\u00ae (Pertuzumab) and Prolia\u00ae\/Xgeva\u00ae (Denosumab) Biosimilar Candidates. Organon. June 13, 2022. Accessed April 14, 2026. <a rel=\"nofollow\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.organon.com%2Fnews%2Forganon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-prolia-xgeva-denosumab-biosimilar-candidates%2F&amp;esheet=54524874&amp;newsitemid=20260429686426&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.organon.com%2Fnews%2Forganon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-prolia-xgeva-denosumab-biosimilar-candidates%2F&amp;index=16&amp;md5=86a336d6aa9abb99886799171bc9d35c\">https:\/\/www.organon.com\/news\/organon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-prolia-xgeva-denosumab-biosimilar-candidates\/<\/a><\/p>\n<\/td>\n<\/tr>\n<\/table>\n<p>\n\u00a0<\/p>\n<p><img decoding=\"async\" alt=\"\" src=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260429686426r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" style=\"width:0;height:0\" \/><span class=\"bwct31415\" \/><\/p>\n<p id=\"mmgallerylink\"><span id=\"mmgallerylink-phrase\">View source version on businesswire.com: <\/span><span id=\"mmgallerylink-link\"><a href=\"https:\/\/www.businesswire.com\/news\/home\/20260429686426\/en\/\" rel=\"nofollow\">https:\/\/www.businesswire.com\/news\/home\/20260429686426\/en\/<\/a><\/span><\/p>\n<p><b>Organon Media Contacts:<\/b><\/p>\n<p>\nKarissa Peer<br \/>\n<br \/>(614) 314 8094<\/p>\n<p>\nSelena Dhanak<br \/>\n<br \/>+44 (7919) 914475<\/p>\n<p><b>Organon Investor Contacts:<\/b><\/p>\n<p>\nJennifer Halchak<br \/>\n<br \/>(201) 275-2711<\/p>\n<p>\nRenee McKnight<br \/>\n<br \/>(551) 204-6129<\/p>\n<p><b>Henlius Media Contacts:<\/b><\/p>\n<p>\nJanice Han<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:jiayi_han@henlius.com\">jiayi_han@henlius.com<\/a><\/p>\n<p>\nBella Zhou<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:wenting_zhou@henlius.com\">wenting_zhou@henlius.com<\/a><\/p>\n<p><b>Henlius Investor Contact:<\/b><\/p>\n<p>\nVenus Hu<br \/>\n<br \/><a rel=\"nofollow\" href=\"mailto:junyan_Hu@henlius.com\">junyan_Hu@henlius.com<\/a><\/p>\n<p><b>KEYWORDS:<\/b> New Jersey North America United States Asia Pacific Europe China<\/p>\n<p><b>INDUSTRY KEYWORDS:<\/b> Other Health Research General Health Pharmaceutical Oncology Consumer Clinical Trials Science Women Biotechnology Other Science Health<\/p>\n<p><b>MEDIA:<\/b><\/p>\n<table cellpadding=\"3\" cellspacing=\"3\">\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260429686426\/en\/1899942\/3\/Organon_Logo_No_tagline.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><b>Logo<\/b><\/font><\/td>\n<\/tr>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20260429686426\/en\/2788226\/3\/Henlius_Logo.jpg\" alt=\"Logo\" \/><\/td>\n<\/tr>\n<tr>\n<td><font face=\"Arial\" size=\"2\"><\/font><\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"<p>European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe SHANGHAI, China &amp; JERSEY CITY, N.J.&#8211;(BUSINESS WIRE)&#8211; Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for POHERDY\u00ae (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 This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20260429686426\/en\/ \u201cAs the first, and currently the only, pertuzumab biosimilar in Europe, the EC\u2019s 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 &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe&#8221;<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-955748","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe SHANGHAI, China &amp; JERSEY CITY, N.J.&#8211;(BUSINESS WIRE)&#8211; Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for POHERDY\u00ae (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 This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20260429686426\/en\/ \u201cAs the first, and currently the only, pertuzumab biosimilar in Europe, the EC\u2019s 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 &hellip; Continue reading &quot;European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe&quot;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\/\" \/>\n<meta property=\"og:site_name\" content=\"Market Newsdesk\" \/>\n<meta property=\"article:published_time\" content=\"2026-04-29T09:33:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260429686426r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\" \/>\n<meta name=\"author\" content=\"Newsdesk\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Newsdesk\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"8 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\\\/\"},\"author\":{\"name\":\"Newsdesk\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/#\\\/schema\\\/person\\\/482f27a394d4fda80ecb5499e519d979\"},\"headline\":\"European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe\",\"datePublished\":\"2026-04-29T09:33:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\\\/\"},\"wordCount\":1540,\"image\":{\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/cts.businesswire.com\\\/ct\\\/CT?id=bwnews&amp;sty=20260429686426r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en\",\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\\\/\",\"url\":\"https:\\\/\\\/www.marketnewsdesk.com\\\/index.php\\\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\\\/\",\"name\":\"European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe - 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Market Newsdesk","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\/","og_locale":"en_US","og_type":"article","og_title":"European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe - Market Newsdesk","og_description":"European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe SHANGHAI, China &amp; JERSEY CITY, N.J.&#8211;(BUSINESS WIRE)&#8211; Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced the European Commission (EC) has granted marketing authorization for POHERDY\u00ae (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 This press release features multimedia. View the full release here: https:\/\/www.businesswire.com\/news\/home\/20260429686426\/en\/ \u201cAs the first, and currently the only, pertuzumab biosimilar in Europe, the EC\u2019s 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 &hellip; Continue reading \"European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe\"","og_url":"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\/","og_site_name":"Market Newsdesk","article_published_time":"2026-04-29T09:33:00+00:00","og_image":[{"url":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260429686426r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","type":"","width":"","height":""}],"author":"Newsdesk","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Newsdesk","Est. reading time":"8 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\/#article","isPartOf":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\/"},"author":{"name":"Newsdesk","@id":"https:\/\/www.marketnewsdesk.com\/#\/schema\/person\/482f27a394d4fda80ecb5499e519d979"},"headline":"European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe","datePublished":"2026-04-29T09:33:00+00:00","mainEntityOfPage":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\/"},"wordCount":1540,"image":{"@id":"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\/#primaryimage"},"thumbnailUrl":"https:\/\/cts.businesswire.com\/ct\/CT?id=bwnews&amp;sty=20260429686426r1&amp;sid=flmnd&amp;distro=nx&amp;lang=en","inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\/","url":"https:\/\/www.marketnewsdesk.com\/index.php\/european-commission-ec-approves-henlius-and-organons-poherdy-pertuzumab-the-first-approved-biosimilar-to-perjeta-pertuzumab-in-europe\/","name":"European Commission (EC) Approves Henlius and Organon\u2019s POHERDY\u00ae (pertuzumab), the First Approved Biosimilar to PERJETA (pertuzumab) in Europe - 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