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		<meta data-vue-meta="ssr" property="og:title" content="Xbrane Plans to Resubmit BLA to US FDA in March 2026 for Lucentis Biosimilar | Market Scope" data-vmid="og:title"><meta data-vue-meta="ssr" property="og:description" content="Sweden’s Xbrane Biopharma announced Nov. 19 that it would resubmit the biologics license application (BLA) for its Lucentis (ranibizumab) biosimilar to the US FDA in March 2026. A complete response letter from the FDA in October 2025 cited unresolved issues at one of Xbrane’s contract manufacturer production sites. Corrective work is ongoing, Xbrane said, and will be completed in connection with a planned winter shutdown and related production line requalification. That delays the timeline fo..." data-vmid="og:description"><meta data-vue-meta="ssr" property="og:url" content="//www.market-scope.com/pages/news/8806/xbrane-plans-to-resubmit-bla-to-us-fda-in-march-2026-for-lucentis-biosimilar" data-vmid="og:url"><meta data-vue-meta="ssr" property="og:type" content="article" data-vmid="og:type"><meta data-vue-meta="ssr" property="article:published_time" content="2025-11-26T00:00:00.000Z" data-vmid="article:published_time"><meta data-vue-meta="ssr" name="image" property="og:image" content="https://www.market-scope.com/files/uploads/images/2024/01/Xbrane%20logo.png" data-vmid="og:image"><meta data-vue-meta="ssr" name="author" content="Jennie Crabbe" data-vmid="author"><meta data-vue-meta="ssr" name="description" content="Sweden’s Xbrane Biopharma announced Nov. 19 that it would resubmit the biologics license application (BLA) for its Lucentis (ranibizumab) biosimilar to the U..." data-vmid="description">
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All Rights reserved.</p></footer></div> <!----> <!----> <!----></div> <div id="invisible-recaptcha" data-sitekey="6LcfrXEUAAAAAL8oovQG9EMVvWYIrcgcHP2eWtjb" class="g-recaptcha g-recaptcha--left g-recaptcha--mobile-hidden g-recaptcha--desktop-hidden"></div> <!----></div><script>window.__INITIAL_STATE__={"companyNames":[],"articles":[],"article":{"id":8806,"position":612,"enabled":1,"draft":0,"author_uid":5164,"author_custom":"","title":"Xbrane Plans to Resubmit BLA to US FDA in March 2026 for Lucentis Biosimilar","slug_auto":"xbrane-plans-to-resubmit-bla-to-us-fda-in-march-2026-for-lucentis-biosimilar","slug_override":null,"slug_history":null,"meta_title":null,"content":"\u003Chtml\u003E\u003Cbody\u003E\u003Cp style=\"text-align:center\"\u003E\u003Cimg alt=\"Xbrane Plans to Resubmit BLA to US FDA in March 2026 for Lucentis Biosimilar\" height=\"130\" src=\"\u002Ffiles\u002Fuploads\u002Fimages\u002F2024\u002F01\u002FXbrane%20logo.png\" width=\"325\" class=\"img-thumbnail \"\u003E\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003ESweden&rsquo;s Xbrane Biopharma announced Nov. 19 that it would resubmit the biologics license application (BLA) for its Lucentis (ranibizumab) biosimilar to the US FDA in March 2026.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EA complete response letter from the FDA in October 2025 cited unresolved issues at one of Xbrane&rsquo;s contract manufacturer production sites. Corrective work is ongoing, Xbrane said, and will be completed in connection with a planned winter shutdown and related production line requalification.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EThat delays the timeline for resubmission until March 2026, Xbrane said. The company said it expects that the FDA will set a target action date for the BLA in September 2026.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EThe biosimilar is branded Ximluci in the EU, where it was approved&nbsp;in November 2022 for wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, retinal vein occlusion, and visual impairment due to choroidal neovascularization in adults.\u003C\u002Fp\u003E\r\n\r\n\u003Cp\u003EXbrane said close to 200 thousand vials have been shipped to end-users since Ximluci was launched in March 2023.\u003C\u002Fp\u003E\r\n\u003C\u002Fbody\u003E\u003C\u002Fhtml\u003E\n","content_hub":null,"content_img_sources":["\u002Ffiles\u002Fuploads\u002Fimages\u002F2024\u002F01\u002FXbrane%20logo.png"],"share_img_filename":null,"preview_img_blurhash":"L73A1}X=V@VBOatRn#eSU[aej^kE","preview_img_width":325,"preview_img_height":130,"meta_description":null,"allowed_roles":"24","inherit_specialty_descendents":1,"rules":[],"publish_date":"2025-11-26","qdrant_id":null,"entities":[{"text":"winter shutdown","type":"event"},{"text":"Sweden","type":"location"},{"text":"EU","type":"location"},{"text":"Ximluci","type":"medication"},{"text":"FDA","type":"organization"},{"text":"US FDA","type":"organization"},{"text":"retinal vein occlusion","type":"symptom"},{"text":"diabetic macular edema","type":"symptom"},{"text":"wet age-related macular degeneration","type":"symptom"},{"text":"diabetic retinopathy","type":"symptom"},{"text":"choroidal neovascularization","type":"symptom"}],"landing_tags":[{"id":171,"namespace":null,"slug":"biosimilars","label":"Biosimilars","counter":144,"created":"2022-08-24T18:13:22+00:00","modified":"2026-08-21T14:44:19+00:00","color":"#04877e"},{"id":33,"namespace":null,"slug":"breaking","label":"Breaking","counter":5263,"created":"2018-09-26T07:21:07+00:00","modified":"2026-09-25T16:42:03+00:00","color":"#bb02cc"},{"slug":"ophthalmic","label":"Ophthalmic","color":"#910030"},{"id":105,"namespace":null,"slug":"regulation","label":"Regulation","counter":1360,"created":"2019-08-23T17:36:42+00:00","modified":"2026-09-25T15:43:37+00:00","color":"#52097c"},{"id":89,"namespace":null,"slug":"retina","label":"Retina","counter":2176,"created":"2019-07-12T20:57:58+00:00","modified":"2026-09-25T16:42:03+00:00","color":"#c46500"}],"recommended_products":[{"id":593,"slug_override":null,"document_original_filename":"2026-Retina-Disease-Model-Cover.pdf","document_cover_filename":null,"document_sample_filename":null,"product_type":{"id":1,"slug":"ophthalmic-comprehensive-reports","name":"Ophthalmic Comprehensive Reports","attributes_separator":", ","pricing_models":[{"month_interval":0,"_joinData":{"id":1,"pricing_model_id":1,"product_type_id":1}}]},"product_type_attributes":[{"product_type_id":1,"attribute":"topic","_joinData":{"id":1443,"product_type_attribute_id":1,"product_id":593,"value":"2026 Retinal Disease Model"}},{"product_type_id":1,"attribute":"month","_joinData":{"id":1444,"product_type_attribute_id":2,"product_id":593,"value":"September"}},{"product_type_id":1,"attribute":"year","_joinData":{"id":1445,"product_type_attribute_id":3,"product_id":593,"value":"2026"}}],"tag_list":[],"label":"2026 Retinal Disease Model, September, 2026","slug":"2026-retinal-disease-model-september-2026"},{"id":586,"slug_override":null,"document_original_filename":"2026-Exudative-Retinal-Disease-Pharmaceutical-Market-Report.pdf","document_cover_filename":"2026 Exudative Retina Pharma Cover - 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