{"id":258613,"date":"2026-09-21T10:36:32","date_gmt":"2026-09-21T05:06:32","guid":{"rendered":"https:\/\/univest.in\/blogs-2\/?p=258613"},"modified":"2026-09-21T10:36:32","modified_gmt":"2026-09-21T05:06:32","slug":"biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval","status":"publish","type":"post","link":"https:\/\/univest.in\/blogs-2\/biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval\/","title":{"rendered":"Biocon Share Price in Focus as Its Pertuzumab Becomes the First Biosimilar to Win EMA Backing"},"content":{"rendered":"<p style=\"border-left:4px solid #1F4E79;background:#EBF3FB;padding:10px 16px;font-style:italic;\"><em>Biocon Biologic&#8217;s Pertuzumab biosimilar (Pebrilzo, 420mg) gets positive CHMP opinion from EMA, first biosimilar of its kind to do so. For HER2-positive breast cancer, multiple disease stages.<\/em><\/p>\n<div style=\"background:#F0F9FF;border-left:4px solid #2E7D32;border-radius:6px;padding:14px 18px;margin:18px 0;\">\n<p style=\"margin:0;color:#1F4E79;font-size:14px;\"><strong>Quick Answer<\/strong><\/p>\n<p style=\"margin:8px 0 0;\">Biocon share price is likely to be in focus after Biocon Biologic, a wholly-owned subsidiary of Biocon, announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending marketing authorisation for its Pertuzumab biosimilar, as a 420 mg concentrate solution for infusion under the brand name Pebrilzo, for the treatment of HER2-positive breast cancer across multiple disease stages. This makes Biocon&#8217;s Pertuzumab the first biosimilar of this particular molecule to secure a positive CHMP opinion, a first-mover position in the European biosimilar market for this specific oncology treatment.<\/p>\n<\/p><\/div>\n<p>Biocon share price is set to be in focus after the company&#8217;s wholly-owned subsidiary Biocon Biologic announced that the European Medicines Agency&#8217;s Committee for Medicinal Products for Human Use has issued a positive opinion on its Pertuzumab biosimilar, branded Pebrilzo.<\/p>\n<p>The positive CHMP opinion recommends marketing authorisation for the 420 mg concentrate solution for infusion, for the treatment of HER2-positive breast cancer across multiple disease stages, and importantly marks the first time any biosimilar version of Pertuzumab has secured this kind of positive European regulatory opinion.<\/p>\n<p style=\"margin-top:24px;\"><a href=\"https:\/\/univest.in\/user\/log-in?utm_source=blogs&#038;utm_medium=biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval\"><strong>Click Here &#8211; Get Free Investment Predictions<\/strong><\/a><\/p>\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_65 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title \" >Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/univest.in\/blogs-2\/biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval\/#Why_Being_First_to_Market_Matters_for_a_Biosimilar\" title=\"Why Being First to Market Matters for a Biosimilar\">Why Being First to Market Matters for a Biosimilar<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/univest.in\/blogs-2\/biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval\/#What_a_Positive_CHMP_Opinion_Means_Procedurally\" title=\"What a Positive CHMP Opinion Means Procedurally\">What a Positive CHMP Opinion Means Procedurally<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/univest.in\/blogs-2\/biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval\/#What_This_Means_for_Biocons_Broader_Biosimilars_Business\" title=\"What This Means for Biocon&#8217;s Broader Biosimilars Business\">What This Means for Biocon&#8217;s Broader Biosimilars Business<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/univest.in\/blogs-2\/biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval\/#Conclusion\" title=\"Conclusion\">Conclusion<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/univest.in\/blogs-2\/biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval\/#FAQs\" title=\"FAQs\">FAQs<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/univest.in\/blogs-2\/biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval\/#What_regulatory_milestone_did_Biocon_achieve\" title=\"What regulatory milestone did Biocon achieve?\">What regulatory milestone did Biocon achieve?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/univest.in\/blogs-2\/biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval\/#What_is_Pertuzumab_used_to_treat\" title=\"What is Pertuzumab used to treat?\">What is Pertuzumab used to treat?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/univest.in\/blogs-2\/biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval\/#What_is_a_positive_CHMP_opinion\" title=\"What is a positive CHMP opinion?\">What is a positive CHMP opinion?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/univest.in\/blogs-2\/biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval\/#Why_does_being_the_first_biosimilar_approval_matter_commercially\" title=\"Why does being the first biosimilar approval matter commercially?\">Why does being the first biosimilar approval matter commercially?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/univest.in\/blogs-2\/biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval\/#Is_this_the_final_approval_for_Biocons_Pertuzumab_biosimilar\" title=\"Is this the final approval for Biocon&#8217;s Pertuzumab biosimilar?\">Is this the final approval for Biocon&#8217;s Pertuzumab biosimilar?<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/univest.in\/blogs-2\/biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval\/#What_should_investors_watch_next_for_Biocon\" title=\"What should investors watch next for Biocon?\">What should investors watch next for Biocon?<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"Why_Being_First_to_Market_Matters_for_a_Biosimilar\"><\/span><strong>Why Being First to Market Matters for a Biosimilar<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>In the biosimilar industry, being first to secure regulatory approval for a specific molecule in a major market like Europe carries outsized commercial importance, since the first approved biosimilar typically captures a disproportionate share of the market before subsequent competing biosimilars of the same reference drug enter and compress pricing.<\/p>\n<p>Pertuzumab is used specifically for HER2-positive breast cancer, a well-defined and clinically significant cancer subtype, meaning a first-mover biosimilar approval gives Biocon Biologic a meaningful head start in addressing this specific market segment across the European Union before rival biosimilar makers can follow.<\/p>\n<p style=\"margin-top:24px;\"><a href=\"https:\/\/univest.in\/screeners\"><strong>Screen Pharmaceutical and Biosimilar Stocks on Univest<\/strong><\/a><\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_a_Positive_CHMP_Opinion_Means_Procedurally\"><\/span><strong>What a Positive CHMP Opinion Means Procedurally<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>A positive opinion from the CHMP is a recommendation, not the final marketing authorisation itself; the European Commission typically follows the CHMP&#8217;s recommendation in granting formal approval, a process that usually takes a further couple of months after the positive opinion is issued.<\/p>\n<p style=\"font-style:italic;color:#000000;margin:14px 0;\">Also read &#8211; <a href=\"https:\/\/univest.in\/blogs\/nifty-it-stocks-fall-tcs-hcl-infosys-coforge-ai-rally-wall-street\">Nifty IT Stocks Slide as TCS Falls 3%, HCL Tech, Infosys and Coforge Down 2% Each<\/a><\/p>\n<p>For Biocon, this positive opinion is nonetheless the most significant regulatory hurdle cleared in the approval pathway, since the CHMP&#8217;s scientific assessment is the substantive review of the biosimilar&#8217;s safety, efficacy and manufacturing quality relative to the original reference product.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"What_This_Means_for_Biocons_Broader_Biosimilars_Business\"><\/span><strong>What This Means for Biocon&#8217;s Broader Biosimilars Business<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Biocon has built a global biosimilars business spanning oncology, diabetes and other therapeutic areas, and adding a first-to-market oncology biosimilar approval in Europe reinforces the company&#8217;s positioning in one of the most closely watched and clinically important biosimilar categories globally.<\/p>\n<p style=\"font-style:italic;color:#000000;margin:14px 0;\">Also read &#8211; <a href=\"https:\/\/univest.in\/blogs\/10-stocks-to-buy-today-21-september-shortlist\">10 Stocks to Buy Today: A Shortlist Built Around Last Week&#8217;s Confirmed Catalysts<\/a><\/p>\n<p>Investors should watch for the formal European Commission approval following this positive opinion, as well as any subsequent commercial launch timeline and market share commentary from the company, since translating a regulatory win into actual sales momentum will be the next milestone that matters for Biocon&#8217;s oncology biosimilars revenue.<\/p>\n<p style=\"margin-top:24px;\"><em>Download the <a href=\"https:\/\/apps.apple.com\/in\/app\/univest-stocks-investment\/id6443753518\" rel=\"nofollow noopener\" target=\"_blank\">Univest iOS App<\/a> or <a href=\"https:\/\/play.google.com\/store\/apps\/details?id=com.univest.capp&#038;hl=en_IN\" rel=\"nofollow noopener\" target=\"_blank\">Univest Android App<\/a> to track Biocon and other pharmaceutical stocks live.<\/em><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Conclusion\"><\/span><strong>Conclusion<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Biocon Biologic&#8217;s first-to-market positive CHMP opinion for its Pertuzumab biosimilar is a meaningful regulatory milestone in a clinically significant oncology category, though the formal European Commission approval and subsequent commercial launch remain the next steps to watch. Investors should track this approval pathway and the company&#8217;s broader biosimilars pipeline, and should consult a SEBI-registered investment adviser before making investment decisions.<\/p>\n<div style=\"background:#CC0000;border-radius:8px;padding:16px 20px;margin:24px 0;\">\n<p style=\"color:#FFFFFF;font-size:13px;line-height:1.7;margin:0;\"><strong style=\"color:#FFFFFF;\">Disclaimer:<\/strong> Data and figures in this article are sourced from publicly available information. These may or may not be accurate. Please verify all data with the official NSE (nseindia.com) and BSE (bseindia.com) websites before making any investment decision. Investments in securities are subject to market risk. This content is for educational purposes only and is not investment advice by Univest (SEBI RA INH000013776).<\/p>\n<\/p><\/div>\n<h2><span class=\"ez-toc-section\" id=\"FAQs\"><\/span><strong>FAQs<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3><span class=\"ez-toc-section\" id=\"What_regulatory_milestone_did_Biocon_achieve\"><\/span><strong>What regulatory milestone did Biocon achieve?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>Ans.<\/strong> Biocon Biologic&#8217;s Pertuzumab biosimilar, branded Pebrilzo, became the first biosimilar of its kind to secure a positive opinion from the EMA&#8217;s Committee for Medicinal Products for Human Use.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"What_is_Pertuzumab_used_to_treat\"><\/span><strong>What is Pertuzumab used to treat?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>Ans.<\/strong> Pertuzumab is used for the treatment of HER2-positive breast cancer across multiple disease stages.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"What_is_a_positive_CHMP_opinion\"><\/span><strong>What is a positive CHMP opinion?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>Ans.<\/strong> It is a scientific recommendation from the EMA&#8217;s Committee for Medicinal Products for Human Use that typically precedes formal marketing authorisation from the European Commission.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Why_does_being_the_first_biosimilar_approval_matter_commercially\"><\/span><strong>Why does being the first biosimilar approval matter commercially?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>Ans.<\/strong> The first approved biosimilar for a given molecule typically captures a disproportionate share of the market before competing biosimilars enter and compress pricing.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Is_this_the_final_approval_for_Biocons_Pertuzumab_biosimilar\"><\/span><strong>Is this the final approval for Biocon&#8217;s Pertuzumab biosimilar?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>Ans.<\/strong> Not yet. The European Commission typically follows the CHMP&#8217;s positive opinion in granting formal marketing authorisation, a process that usually takes a further couple of months.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"What_should_investors_watch_next_for_Biocon\"><\/span><strong>What should investors watch next for Biocon?<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><strong>Ans.<\/strong> Investors should track the formal European Commission approval, the subsequent commercial launch timeline, and Biocon&#8217;s broader oncology biosimilars pipeline.<\/p>\n<div class=\"faq-schema\"><script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"What regulatory milestone did Biocon achieve?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Biocon Biologic's Pertuzumab biosimilar, branded Pebrilzo, became the first biosimilar of its kind to secure a positive opinion from the EMA's Committee for Medicinal Products for Human Use.\"}},{\"@type\":\"Question\",\"name\":\"What is Pertuzumab used to treat?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Pertuzumab is used for the treatment of HER2-positive breast cancer across multiple disease stages.\"}},{\"@type\":\"Question\",\"name\":\"What is a positive CHMP opinion?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"It is a scientific recommendation from the EMA's Committee for Medicinal Products for Human Use that typically precedes formal marketing authorisation from the European Commission.\"}},{\"@type\":\"Question\",\"name\":\"Why does being the first biosimilar approval matter commercially?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"The first approved biosimilar for a given molecule typically captures a disproportionate share of the market before competing biosimilars enter and compress pricing.\"}},{\"@type\":\"Question\",\"name\":\"Is this the final approval for Biocon's Pertuzumab biosimilar?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Not yet. The European Commission typically follows the CHMP's positive opinion in granting formal marketing authorisation, a process that usually takes a further couple of months.\"}},{\"@type\":\"Question\",\"name\":\"What should investors watch next for Biocon?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"Investors should track the formal European Commission approval, the subsequent commercial launch timeline, and Biocon's broader oncology biosimilars pipeline.\"}}]}<\/script><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Biocon share price is in focus after its Pertuzumab biosimilar, Pebrilzo, became the first such biosimilar to secure a positive CHMP opinion from the EMA.<\/p>\n","protected":false},"author":29,"featured_media":258612,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[842],"tags":[1244,6212],"class_list":["post-258613","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news","tag-biocon","tag-pertuzumab-biosimilar"],"metadata":{"rank_math_internal_links_processed":["1"],"_thumbnail_id":["258612"],"rank_math_title":["Biocon Share Price on Pertuzumab EMA Approval"],"rank_math_description":["Biocon share price is in focus after its Pertuzumab biosimilar, Pebrilzo, became the first such biosimilar to secure a positive CHMP opinion from the EMA."],"rank_math_focus_keyword":["Biocon share price"],"rank_math_robots":["a:2:{i:0;s:7:\"noindex\";i:1;s:8:\"nofollow\";}"]},"jetpack_sharing_enabled":true,"jetpack_featured_media_url":"https:\/\/univest.in\/blogs-2\/wp-content\/uploads\/2026\/09\/biocon-share-price-pertuzumab-biosimilar-ema-chmp-approval.png","_links":{"self":[{"href":"https:\/\/univest.in\/blogs-2\/wp-json\/wp\/v2\/posts\/258613","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/univest.in\/blogs-2\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/univest.in\/blogs-2\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/univest.in\/blogs-2\/wp-json\/wp\/v2\/users\/29"}],"replies":[{"embeddable":true,"href":"https:\/\/univest.in\/blogs-2\/wp-json\/wp\/v2\/comments?post=258613"}],"version-history":[{"count":1,"href":"https:\/\/univest.in\/blogs-2\/wp-json\/wp\/v2\/posts\/258613\/revisions"}],"predecessor-version":[{"id":258614,"href":"https:\/\/univest.in\/blogs-2\/wp-json\/wp\/v2\/posts\/258613\/revisions\/258614"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/univest.in\/blogs-2\/wp-json\/wp\/v2\/media\/258612"}],"wp:attachment":[{"href":"https:\/\/univest.in\/blogs-2\/wp-json\/wp\/v2\/media?parent=258613"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/univest.in\/blogs-2\/wp-json\/wp\/v2\/categories?post=258613"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/univest.in\/blogs-2\/wp-json\/wp\/v2\/tags?post=258613"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}