Xlucane (ranibizumab biosimilar) / Stada, Xbrane, Helvetic - LARVOL DELTA

XBRANE UPDATES ON TIMING FOR RESUBMISSION OF THE BLA FOR ITS RANIBIZUMAB BIOSIMILAR CANDIDATE TO FDA (Xbrane Press Release) - "Subsequently, the site received additional information from the FDA requesting corrective actions related to two specific observations concerning another product that was also included in the scope of the FDA inspection. These corrective actions must be completed before the FDA can approve Xbranes BLA. The work related to these corrective actions is ongoing and will be completed in connection with a planned winter shutdown and related production line re-qualification. Hence, Xbrane will be able to re-submit its BLA post completion of these corrective actions, in March 2026. Xbrane expects a 6 months review process by the FDA of the re-submitted BLA and hence expects a BsUFA date in September 2026."

FDA approval • FDA filing • Age-related Macular Degeneration • Retinal Vein Occlusion

Xbrane Biopharma AB…announce that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the Company’s Biologics License Application (BLA) for its ranibizumab biosimilar candidate for treatment of retinal disorders. (Xbrane Press Release) - "FDA conducted re-inspections during Q3 2025 of both production sites involved in production of drug substance and drug product respectively. Thorough evidence on corrective actions to the respective observations was submitted by both production sites in due time to the FDA. Xbrane has during the weekend received a CRL from FDA stating unresolved observations following the inspection at one of the production sites without further specification. No other issues related to the BLA were mentioned by the FDA in the CRL."

CRL • Age-related Macular Degeneration

Evaluation of XSB-001 (Ranibizumab Biosimilar) Physicochemical and Biological Stability in Prepared Syringes for Intravitreal Injection. (PubMed, Adv Ther) - "These findings support the extended stability of XBS-001 stored in unopened vials and subsequently prepared syringes (and independent of syringe type), optimizing patient care and treatment management efficiency."

Journal • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

OneSource and Xbrane Biopharma Announces Strategic Biosimilars Manufacturing Partnership for the Global Markets (Passionate In Marketing) - "OneSource Specialty Pharma Limited...and Xbrane Biopharma AB...announced a strategic partnership focused on the commercial manufacturing of Xbrane’s biosimilar portfolio...The lead candidate Ximluci (a ranibizumab biosimilar) is granted market authorization approval in Europe (launched in 2023) and is now under the approval process for the US launch...The collaboration aims to strengthen Xbrane’s global supply chain, while enabling OneSource to accelerate regulatory approvals, including from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), for its biologics drugs substance facility. As part of the collaboration, OneSource has also participated in Xbrane’s latest funding round, reinforcing the long-term strategic alignment between the two companies."

Licensing / partnership • Age-related Macular Degeneration • Retinal Vein Occlusion

Xbrane Biopharma AB updates on US FDA BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS (ranibizumab) (Xbrane Press Release) - "Xbrane re-submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS (ranibizumab) to the FDA (US Food and Drug Administration) in December 2024. After submission of additional documentation from the manufacturing sites, the official review cycle was initiated. FDA has now communicated October 21st 2025 as the BsUFA date (decision date). An approval would be subject to successful re-inspections of manufacturing sites. Both Manufacturing sites have addressed observations from FDA inspections during 2024 and submitted the relevant documentation to FDA. Xbrane is fully committed to advance its investigational biosimilar candidate towards approval in the United States as quickly as possible to provide a much needed, cost-efficient treatment alternative for patients suffering from age-related macular degeneration (AMD), retinal vein occlusion (RVO) or myopic choroidal neovascularization (mCNV)."

BsUFA date • FDA filing • Age-related Macular Degeneration • Retinal Disorders • Retinal Vein Occlusion

Xbrane has entered into an agreement to sell XB003 (Cimzia biosimilar candidate) and parts of its organization to Alvotech for a total consideration of SEK 275 million (Xbrane Press Release) - "Xbrane Biopharma...has entered into an agreement to sell XB003 (biosimilar candidate to Cimzia) and parts of its organization, including approximately 40 employees and laboratory equipment, to Alvotech for a total consideration of approximately SEK 275 million. XB003 is the most advanced biosimilar candidate to Cimzia under development, representing approx. 25% of the competitive adjusted adressable market of Xbranes portfolio...Closing of the transaction is subject to approval from Xbrane's shareholders at an Extraordinary General Meeting (the 'EGM') to be held on 14 April 2025 as well as FDI approval...Xbrane will retain Ximluci (biosimilar to Lucentis) and Xdivane (biosimilar candidate to Opdivo)....A service agreement will be established between the parties under which Xbrane can get support from the transitioned part of the organization. The reduction in Xbrane's organization will reduce annual fixed costs by approximately SEK 120 million."

Commercial • Diabetic Macular Edema • Diabetic Retinopathy • Head and Neck Cancer • Immunology • Kidney Cancer • Liver Cancer • Psoriasis • Rheumatoid Arthritis • Skin Cancer • Wet Age-related Macular Degeneration

XBRANE RE-SUBMITS BLA FOR RANIBIZUMAB BIOSIMILAR CANDIDATE TO FDA (Xbrane Press Release) - "Xbrane Biopharma AB...has re-submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS (ranibizumab) to FDA (US Food and Drug Administration). Xbrane submitted the BLA for its investigational biosimilar candidate to LUCENTIS (ranibizumab) to the FDA in April 2023 and subsequently received a Complete Response Letter (CRL) in April 2024...The review cycle of a re-submitted BLA is typically 6 months...cost-efficient treatment alternative for patients suffering from Age-related Macular Degeneration (AMD), retinal vein occlusion (RVO) or myopic choroidal neovascularization (mCNV)."

FDA filing • Age-related Macular Degeneration • Ophthalmology • Retinal Vein Occlusion

XBRANE BIOPHARMA IS FOCUSING THE DEVELOPMENT PORTFOLIO AND INTRODUCING A COST-SAVINGS SCHEME (Xbrane Press Release) - "Xbrane Biopharma AB...announced today that it is focusing the company's development portfolio and, consequently, the development of Xtrudane (biosimilar candidate to Keytruda) has been terminated. Furthermore, a cost-savings scheme is being introduced which is expected to result in around SEK 50 million in annual savings when fully implemented. Xbrane's main aim is to achieve a positive cash flow as soon as possible and as previously announced, by no later than Q1 2025. Therefore, Xbrane’s board has decided to focus the development portfolio on biosimilar candidates with established commercialization partners: Ximluci (Lucentis biosimilar), BIIB801 (Cimzia biosimilar candidate), and Xdivane (Opdivo biosimilar candidate) with the ambition of out-licensing the latter in the near future. Xdarzane (Darzalex biosimilar candidate) is being maintained in the portfolio..."

Clinical • Age-related Macular Degeneration • Crohn's disease • Diabetic Macular Edema • Immunology • Inflammatory Bowel Disease • Ophthalmology • Psoriatic Arthritis • Retinal Vein Occlusion • Rheumatoid Arthritis • Wet Age-related Macular Degeneration

STADA and Xbrane weigh options for ranibizumab biosimilar candidate (Pharmabiz) - "STADA Arzneimittel AG and Xbrane Biopharma AB are considering options, including out-licensing, for their co-developed ranibizumab biosimilar candidate in North America. The two companies and previous commercialization partner, Bausch + Lomb, have mutually agreed to discontinue their license agreement for North America. Bausch + Lomb will now focus on other strategic priorities. An upfront payment of US$ 5 million made by Bausch + Lomb in 2020 is non-refundable, but no further payments will be made to STADA and Xbrane....The partners are currently exploring all options, including licensing to an external commercial partner, as well as commercializing the product themselves."

Licensing / partnership • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Xbrane announce U.S. FDA filing acceptance for a Lucentis (ranibizumab) biosimilar candidate (Market Screener) - "Xbrane Biopharma AB...announced the acceptance of the supplemental Biologics License Application (sBLA) for a Lucentis® (ranibizumab) biosimilar candidate by the US Food and Drug Administration (FDA). The regulatory process can therefore be initiated with a Biosimilar User Fee Amendment (BsUFA) goal date of April 21st, 2024....The FDA filing is supported by a comprehensive Comparative Analytical Assessment of the biosimilar candidate vs. Lucentis (ranibizumab) and positive data from a randomized, double-masked, multi-center study evaluating efficacy, safety, pharmacokinetics, and immunogenicity of the ranibizumab biosimilar in patients with wAMD."

BsUFA date • sBLA • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

STADA and Xbrane launch Ximluci as ranibizumab biosimilar in Germany (Market Screener) - "STADA Arzneimittel AG (STADA) and Xbrane Biopharma AB...jointly present their new product Ximluci®, a ranibizumab biosimilar, for the market launch in Germany. Ximluci® aims to offer ophthalmologists and their patients a cost-effective alternative to the reference product and to provide a universal option for the treatment of certain retinal disorders caused by damage to the retina and particularly the macula (nAMD, DME, PDR, RVO and CNV). As a biosimilar, Ximluci® offers comparable efficacy, safety and immunogenicity profile to the reference product. Ximluci has already started shipping in some European countries such as Germany, while others are currently preparing for launch."

Launch Europe • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Xbrane has carried out a directed share issue and an issue of convertible bonds raising gross proceeds of approximately SEK 350 million (Market Screener) - "The Board of Directors of Xbrane Biopharma AB...has, based on the authorization granted by the annual general meeting held on 4 May 2023, and in accordance with what the Company indicated in a press release on 22 May 2023, resolved on a directed share issue of approximately SEK 125 million at a subscription price of SEK 73.1 per share...A number of Swedish and international institutional investors, including healthcare focused investors, have subscribed for shares in the Directed Share Issue. In connection with the Directed Share Issue, the Company has entered into a binding agreement with CVI Investments, Inc. for a convertible bond financing of SEK 250 million in aggregate principal amount, maturing in 2027...The net proceeds from the Transaction will primarily finance: Scale-up of production capacity for Ximluci® to meet demand both in Europe and globally while also reducing production cost (c. 30%)."

Commercial • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

XBRANE submits BLA for ranibizumab biosimilar candidate to FDA (Market Screener) - "Xbrane Biopharma AB...has submitted the BLA (Biologics License Application) for its investigational biosimilar candidate to LUCENTIS® (ranibizumab) to FDA (US Food and Drug Administration)...Within 60 days, FDA is expected to validate and decide to initiate the review of the BLA. Thereafter, Xbrane expects a 10 month review process and hence an approval could take place during the first half of 2024."

BLA • Age-related Macular Degeneration • Ophthalmology • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

STADA and Xbrane launch ranibizumab to support patient access in Europe (Market Screener) - "Ranibizumab biosimilar is being launched in major European markets. Ranibizumab is the first product brought to market through a strategic collaboration between STADA and Xbrane Biopharma AB...marking Xbrane’s first commercial launch and STADA’s first co-development asset, in its growing biosimilars portfolio. Developed and manufactured solely in Europe, ranibizumab is the sixth biosimilar marketed in Europe by STADA, and the first to treat ophthalmologic conditions....The EU marketing authorization was based on a comprehensive comparative analytical assessment and a Phase 3 clinical study..."

Launch Europe • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Comparative Analytical Assessment of Ranibizumab Biosimilar XSB-001 (ARVO 2023) - "Purpose The European Commission has granted pan-EU marketing authorization for XSB-001 (as Ximluci ® ), a ranibizumab biosimilar, as a therapy for retinal vascular disorders. Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

Ophthalmology

"BioStock: Xbranes vd om lanseringen av Ximluci i Europa https://t.co/pTeKQh1aMi" (@CisionNews)

"BioStock: Xbrane's CEO on the launch of Ximluci in Europe https://t.co/7ia9oB9x1Q" (@CisionNews)

Launch Europe

"S2022_003: @Novartis requested a PI in view of Swissfillon‘s involvement in the preparation of pre-filled syringes of a biosimilar of #Lucentis, i.e., #Ximluci (fka #Xlucane) of @STADA / @XbraneBiopharma. See https://t.co/x3QoqDZbCe" (@FPCreview)

STADA and Xbrane secure EU approval for Ximluci (ranibizumab) biosimilar referencing Lucentis (Stada Press Release) - "European Commission grants pan-EU marketing authorization for Ximluci® biosimilar referencing Lucentis® (ranibizumab). Paves way for European launch of Ximluci® early in 2023. The partnership combines Xbrane’s patented protein-expression system and Europe-based production platform with STADA’s experienced clinical salesforce and key-account management teams, 125-year heritage and extensive sales and marketing expertise throughout Europe."

European regulatory • Launch Europe • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

XPLORE: Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD (clinicaltrials.gov) - P3 | N=582 | Completed | Sponsor: Xbrane Biopharma AB | Active, not recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Xbrane announces positive top-line results from the pivotal phase III equivalence trial for Xlucane - a biosimilar candidate to Lucentis (Market Screener) - P3 | N=580 | XPLORE (NCT03805100) | Sponsor: Xbrane Biopharma AB | "Xbrane Biopharma AB...announced top-line results from the 12-months data from the Phase III equivalence trial Xplore with the Lucentis® biosimilar candidate Xlucane™, these data support the ongoing registration process for Xlucane™...Further, the full 12-months data, as per Xbrane´s assessment, reveals no clinically meaningful differences between Xlucane™ and Lucentis®."

P3 data: top line • Ophthalmology • Wet Age-related Macular Degeneration

Pipeline therapies for neovascular age related macular degeneration. (PubMed, Int J Retina Vitreous) - "Prior treatments have included focal laser therapy, verteporfin (Visudyne, Bausch and Lomb, Rochester, New York) ocular photodynamic therapy, transpupillary thermotherapy, intravitreal steroids and surgical excision of choroidal neovascular membranes. Currently, the major therapies in AMD focus on the VEGF-A pathway, of which the most common are bevacizumab (Avastin; Genentech, San Francisco, California), ranibizumab (Lucentis; Genentech, South San Francisco, California), and aflibercept (Eylea; Regeneron, Tarrytown, New York)...Cheaper alternatives, including ranibizumab biosimilars, include razumab (Intas Pharmaceuticals Ltd., Ahmedabad, India), FYB 201 (Formycon AG, Munich, Germany and Bioeq Gmbh Holzkirchen, Germany), SB-11 (Samsung Bioepsis, Incheon, South Korea), xlucane (Xbrane Biopharma, Solna, Sweden), PF582 (Pfnex, San Diego, California), CHS3551 (Coherus BioSciences, Redwood City, California). Additionally, aflibercept biosimilars under development include..."

Journal • Review • Age-related Macular Degeneration • Gene Therapies • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

XBRANE BIOPHARMA AB ANNOUNCES THAT PARTNER STADA’S MARKETING AUTHORIZATION APPLICATION FOR RANIBIZUMAB IS SUBMITTED AND VALIDATED BY EUROPEAN MEDICINES AGENCY (Xbrane Press Release) - "Xbrane Biopharma AB...announces that a Marketing Authorization Application (MAA) for biosimilar ranibizumab submitted by its co-development and commercialization partner, STADA Arzneimittel AG, has been validated by the European Medicines Agency (EMA)...The EMA validation confirms that the application is sufficiently complete to begin a formal review process. The Company anticipates an EMA review for the biosimilar candidate, which was developed under the Xlucane™ name, will be according to standard timelines."

European regulatory • Diabetic Macular Edema • Ophthalmology • Wet Age-related Macular Degeneration

XPLORE: Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD (clinicaltrials.gov) - P3; N=580; Active, not recruiting; Sponsor: Xbrane Biopharma AB; Trial primary completion date: Dec 2021 ➔ May 2021

Clinical • Trial primary completion date • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

XPLORE: Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD (clinicaltrials.gov) - P3; N=580; Active, not recruiting; Sponsor: Xbrane Biopharma AB; Recruiting ➔ Active, not recruiting

Enrollment closed • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration