{"success":true,"data":{"pressRelease":{"id":"168478","rtpr_id":"nGNX7TVmXn-20261014","ticker":"ALVO","exchange":"NASDAQ","all_tickers":["ALVO"],"title":"Alvotech and Advanz Pharma announce first known regulatory submission worldwide for proposed biosimilar to Eylea® 8 mg","author":"Globe Newswire","published_at":"2026-10-14T08:30:00.416Z","article_body":"AVT29 submitted to the European Medicines Agency as a line extension to the\nexisting marketing authorization for Mynzepli(®) (aflibercept 2 mg)\n\nHigh-dose aflibercept offers the potential to reduce treatment frequency for\npatients with retinal diseases\n\nREYKJAVIK, Iceland and LONDON, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Alvotech\n(NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the\ndevelopment and manufacture of biosimilar medicines for patients worldwide,\nand Advanz Pharma Holdco Limited (“Advanz Pharma”), a global\npharmaceutical company with a strategic focus on specialty, hospital, and rare\ndisease medicines, today announced the submission of a European regulatory\napplication for AVT29, a proposed biosimilar to Eylea(®) 8 mg (aflibercept\n114.3 mg/mL), which is marketed as Eylea HD(®) in the United States. Based on\npublicly available information, this marks the first regulatory submission\nworldwide for a proposed biosimilar to Eylea(®) 8mg.\n\nThe application was submitted as a line extension to the existing European\nmarketing authorization for Mynzepli(®) (AVT06, 2 mg aflibercept, 40 mg/ mL),\nAlvotech’s biosimilar to Eylea(®) 2 mg.\n\nEylea(®) is used to treat certain retinal diseases through injections\ndirectly into the eye. According to the approved European product information,\nthe 8mg formulation allows treatment intervals of 16 weeks for certain\npatients, compared with the standard eight-week maintenance interval for the\noriginal 2 mg formulation, potentially reducing the frequency of maintenance\ninjections and reducing the treatment burden for patients([)(2)(]).\n\nAccording to publicly reported financial results, the 8mg formulation\naccounted for approximately 57% of combined global Eylea(®) 2mg and 8mg sales\nby value in the second quarter of 2026, up from approximately 30% in the same\nperiod in 2025([)(3)(]).\n\n“To our knowledge, this is the first regulatory submission anywhere in the\nworld for a proposed biosimilar to Eylea 8 mg. This is an important\nachievement for Alvotech and demonstrates the strength of our in-house\ndevelopment capabilities,” said Lisa Graver, Chief Executive Officer of\nAlvotech. “We recognized early the potential of high-dose aflibercept and\ninvested in developing both the 2 mg and 8 mg formulations. Building on the\nEuropean approval of Mynzepli, this milestone positions us at the forefront of\nthe next wave of aflibercept biosimilars and reflects our commitment to\nbroadening access to high-quality biologic medicines.”\n\nSteffen Wagner, Chief Executive Officer of Advanz Pharma, said: “This\nsubmission represents an important milestone in our partnership with Alvotech\nand our shared commitment to improving access to high-quality, affordable\nmedicines. Following the European approval of Mynzepli, we are pleased to be\nadvancing a high-dose formulation that could offer additional treatment\noptions for patients and healthcare professionals across Europe.”\n\nMynzepli(®) received European Commission approval in August 2025 as a\nbiosimilar to Eylea(®) 2 mg (aflibercept 40 mg/mL), in both vial and\nprefilled syringe presentations, for the treatment of various retinal\ndiseases.\n\nUnder the companies’ partnership agreement, Alvotech is responsible for\ndevelopment and commercial supply of AVT06 and AVT29, while Advanz Pharma is\nresponsible for registration and commercialization in Europe. Advanz Pharma\nholds exclusive commercialization rights in Europe, except in Germany and\nFrance, where the rights are semi-exclusive.\n\nFor further information, contact:\n\nAlvotech Media\nBenedikt Stefansson\nSarah MacLeod\nalvotech.media@alvotech.com\n\nAlvotech Investors\nDr. Balaji V Prasad\nBenedikt Stefansson\nMikaela Vilchez\nalvotech.ir@alvotech.com\n\nAdvanz Pharma\nCourtney Baines\ncourtney.baines@advanzpharma.com\n\nAbout AVT06\nAVT06 is a biosimilar to Eylea(®) (aflibercept). Aflibercept binds vascular\nendothelial growth factors (VEGF), inhibiting the binding and activation of\nVEGF receptors, neovascularization, and vascular permeability([)(1]). AVT06\nhas been approved under the brand names Mynzepli(®) (aflibercept) and\nAfiveg(®) (aflibercept) in the European Economic Area, Mynzepli(®)\n(aflibercept) in the United Kingdom and under the name AFLIBERCEPT BS for\nmarketing in Japan.\n\nAbout AVT29\nAVT29 is Alvotech’s proposed biosimilar to Eylea(®) 8 mg (aflibercept), a\nbiologic medicine used to treat retinal diseases that can cause vision loss.\nAVT29 is an investigational product and has not received regulatory approval.\nBiosimilarity has not yet been established by regulatory authorities.\n\nUse of trademarks\nEylea(®) is a registered trademark of Regeneron Pharmaceuticals Inc. and\nBayer AG.\n\nSources\n([1)(])\n(https://www.globenewswire.com/Tracker?data=LPi6n_0C5na9H7AkrMjGufSneRp940rRy3OpW9egj-huxSJnIBcF1Mj_btrtifRvtBsmXYitmvOpYRJLfc4Bsm5ocgYXhzyC453nvF_nFYDHPF5XEUlk1KHiOeGiLggt-zamLZzqZwP6MiFUCmmQJsZZOIJ4xa-My5HGjD6WoVj-8fJMy0MeDRhnRua_VI8p)\nMynzepli\n(https://www.globenewswire.com/Tracker?data=UhHJrgZnmiRWLq27KKtY5J0LrITwBab3V-IOgW8niJf2pOjCTVQVB2igIvBhHfGNJKOVr3XMhf2UuwdzT7hNCcOHdnBn_thrAe3B_mG7cl1kxeJQDLWIg7GocObBXB0EBGE2Ph6PUSZi0Dk4ql7QnC6Y8GlqSk-Xx-jY5wwKGdHSrW69v2Je1AdFw9gLHCBO)(®)\nproduct information\n(https://www.globenewswire.com/Tracker?data=V9yARuVX3M37s827h0g8hcYo0PpFfjsw0G_V9JaScOHcLVC1Sk0spM-7KUQws_AQYi15-1YhKilFD487pAS5cmv9T31uXC8QMZB6a7_R5KRQzx7HZIX-mn2xEnugn-tex5Dly2We-E7V2wqEuLfsQ8hrQkfIwYMxZi_lNh4P_Q3jRkHI12x0VOXSVEitZ3DdNo0OQu-SvnITXk9hl7e5lw==)\n\n([)(2])EMA: Eylea(®) summary of product characteristics\n(https://www.globenewswire.com/Tracker?data=1OkrO-B2VQZgRm_Xypj-hya-wtLXztS9fzPncfqw2Yqk9JxeBGxj5xHIQ8LRfBpYo1GRMCCcVPS5WfGS34IHynfCvjFkhWyzW-ZxUrdhcRFnK_9sKYePPnAFnhDmaLCoAgpSLtAY-oWhwKXM6l1ap3wltUk0EF60aWFVlEMyhE0oLwk_zAGM5xxiO_b4sD2tM8xhJFkOLm8ZqvL-AA4oBkYY_D886F85velQhbPsq18=)\n([)(3)(])Regeneron Pharmaceuticals Inc.: Regeneron Reports Second Quarter 2026\nFinancial and Operating Results\n(https://www.globenewswire.com/Tracker?data=bka-QFVosF7kp3DEK9Fa4A70xhWMZrRmkJpZ6UnJLlnZ1UDZ6xuR1h-v3sEQb3WU7SiwNkfKCUt8VyoYHSEAFL8nqDSwsCx96hvdzUHJeBV6dSire1z0TrqCZsajR8nPAs8tjR7LsPB2mYune9JWgQki6JEzbk9DsKvXh5VVahctIXc-jw-xwAbKvb4dy5CspCCIXU_KdEBDn3VUq7wlih3a4zknd8W2RzJdKtsVTrex_9L1logsbwGuGupjf4RGeMneMQ77qK005p-mSXclnaiJdVcuRpxVEv5jBqnfoZ40pRQXTulWn_nVP-gYr1Eb)\n\nAbout Advanz Pharma\nAdvanz Pharma is a global pharmaceutical company with the purpose to improve\npatients’ lives by providing and enhancing the specialty, hospital, and rare\ndisease medicines they depend on. Our headquarters are in London, UK. We have\ncommercial sales in more than 90 countries globally and have a direct\ncommercial presence in more than 20 countries, including key countries in\nEurope, the US, Canada, and Australia, a Centre of Excellence in Mumbai,\nIndia, as well as an established global distribution and commercialisation\npartner network. Advanz Pharma’s product portfolio and pipeline comprises\ninnovative medicines, specialty generics & biosimilars, and originator brands.\nOur products cover a broad range of therapeutic areas, including hepatology,\ngastroenterology, anti-infectives, critical care, endocrinology, oncology,\nCNS, and, more broadly, rare disease medicines. Our ambition is to be a\npartner of choice for the commercialisation of specialty, hospital, and rare\ndisease medicines in Europe, Canada, and Australia. In line with our ambition,\nwe are partnering with biopharma and development companies to bring medicines\nto patients. For more information, please visit our Website\n(https://www.globenewswire.com/Tracker?data=USOZ7ocyfTbznJBXiYxkLLEMnaI2yFTvL8_S-cWXDyWWuIqZ81mbj8gQIdXdMiZZhcSgFIJamcV-gIK7FsKlaWgpZrvc8utDPmN6EuZrRJ4=)\nor LinkedIn\n(https://www.globenewswire.com/Tracker?data=InH7FFTnK4qdcivE7RzoeTx8pnIJVBCM_DQqoBmOHkG2059F95k98qaEfiXgyBayFDdFQKqawf2qYF8A3jyuG0_5R0zD9A6WMKKIfANJkrRanjUpwl7PQSzQhTPtEM0a).\n\nAbout Alvotech \nAlvotech is a biotechnology company, founded by Robert Wessman, focused solely\non the development and manufacture of biosimilar medicines for patients\nworldwide. Alvotech seeks to be a global leader in the biosimilar space by\ndelivering high-quality, cost-effective products and services, enabled by a\nfully integrated approach and broad in-house capabilities. Five biosimilars\nare already approved and marketed in multiple global markets, including\nbiosimilars to Humira(®) (adalimumab), Stelara(®) (ustekinumab), Simponi(®)\n(golimumab), Eylea(®) (aflibercept) and Prolia(®)/Xgeva(®) (denosumab). The\ncurrent development pipeline includes disclosed biosimilar candidates aimed at\ntreating autoimmune disorders, eye disorders, and cancer. Alvotech has formed\na network of strategic commercial partnerships to provide global reach and\nleverage local expertise in markets that include the United States, Europe,\nJapan, China, and other Asian countries and large parts of South America,\nAfrica and the Middle East. For more information, please visit\nhttps://www.alvotech.com. None of the information on the Alvotech website\nshall be deemed part of this press release.\n\nFor more information, please visit our  website\n(https://www.globenewswire.com/Tracker?data=M-aUNNSbkx2jtY-2J88qPOtG7CHRqeAWlze0kgQXsejyiQqp7Ucr1XiUzP0QSloAlETW5nEAQFyDqXZSTK63_U-S77HMwVbvJd5cwe7-mMoPI6anLSDRBPLQ47yGuAmrYEkrmILmFPkIr8Af1hnA7JE71t6vAh1sQSXLAG-LMeVP7vNzTBiLj2lU8p-dv7V0tULwhOgzYmz_e3HwAXKPqBVoYseeHgcbunnGw9LyFVA=) or\nfollow us on social media on LinkedIn\n(https://www.globenewswire.com/Tracker?data=InH7FFTnK4qdcivE7RzoeXBy_9W2hQf8FlS2E86XT3h99YFkPSK6WeeHee6s_w1J3ZDIaQyWSSsU5j4HNH2jWgDIewHWnDVYWLSdtKRmtMKkb9xO7vPHFTM74v5KXkACg_I3093z4yQ2q8ZU0VziWPLp94gpHiM2YKx2k5etXU2J3zpWVyWsoajFIu7m0mKaYYO8ixPXQIy2r-TfuBJCZfCyC55XoLjFCeIcJ5RSogpDY9QoGS5z1X6MUHJ1n3EA), Facebook\n(https://www.globenewswire.com/Tracker?data=VFSOwwRzP4Tqjr9pKtxIJf9MTt_dJolWr61Az2FuupHxGhk2yP4ALrhs-Szc9u1Sh6y-8aBs9GVjUUAUY5_R_aZikVwKLNuxjPhlVYXobpuyW6ekSs0Ve66r2YKLhIg439IUC5pk2CE4YzucB-9Q2Jrj1iJM0ZaD39F83_kmbUP5vIbae9ZDHXWQjivlr3P0wWmUv6Q3VUDRI4HiJ2dLSU9Z1pShRniklSd5rjSinrHXuubWaS_lRGLX04cBmzH8), Instagram\n(https://www.globenewswire.com/Tracker?data=WIhwAv2-l6JKa4roVbXZGx6g6vrF6VEsfX443zT9cs09Ci-DCncg7JeWLH_Uk1euoAuwmAj3CHLEHtqP-XUb_URD_zVeIIGXtMgMpC8XTUR5RLkGpQisstKpSOyflqFjKObBJB9COG146vKfSt3i0KE1d9IUBhSwjOTvxeP5Jhy0jPuxKD1j9fsHAL7T0AkZkfPm9XinIDtqisdaNDOI_OX9QUm_eoHzV7Pw6ufedUScOdNSdzNL9jrw1v3GwK5U),\nand YouTube\n(https://www.globenewswire.com/Tracker?data=QOFX_du4hN0SWIex9nr3QdBzJA8u2Z9Q5O9KsRddQcG88_9PlIFtorYMB9tCXO5G6kvH7M4g7Kz2LYnJYvDHdi1vgSYpdRQynFtYsMXvwDqQljzH58RiqO8DdgAvTMFq87InLCK2pyJysC0uHCw1Dfb9j2w9PFQvm0xsGPO8KfDmz10B6-k_eEBSptYBQGQxcLE6SDWiQnQz_1uPVR7ccS7VKnHTn8YSJIdAz7uN2FRVFmIO-0D3dkgFIAaDUIBK).\n\nAdvanz Pharma Forward Looking Statements\nCertain statements in this press release are forward-looking statements. These\nstatements may be identified by words such as “anticipate”, \"expectation\",\n\"belief”, \"estimate\", \"plan\", \"target”, “project”, “will”,\n“may”, “should” or \"forecast\" and similar expressions, or by their\ncontext. Although Advanz Pharma believes that these assumptions were\nreasonable when made, by their nature, forward-looking statements involve a\nnumber of risks, uncertainties and assumptions that could cause actual results\nor events to differ materially from those expressed or implied by the\nforward-looking statements. These risks, uncertainties and assumptions could\nadversely affect the outcome and financial consequences of the plans and\nevents described herein. Actual results may differ from those set forth in the\nforward-looking statements as a result of various factors (including, but not\nlimited to, future global economic conditions, changed market conditions\naffecting the industry, intense competition in the markets in which Advanz\nPharma operates, costs of compliance with applicable laws, regulations and\nstandards, diverse political, legal, economic and other conditions affecting\nAdvanz Pharma’s markets, and other factors beyond the control of Advanz\nPharma. Neither Advanz Pharma nor any of its directors, officers, employees,\nadvisors, or any other person is under any obligation to update or keep\ncurrent the information contained in this press release or revise any\nforward-looking statements, whether as a result of new information, future\nevents or otherwise. You should not place undue reliance on forward-looking\nstatements, which speak of the date of this press release. Statements\ncontained in this press release regarding past trends or events should not be\ntaken as a representation that such trends or events will continue in the\nfuture. No obligation is assumed to update any forward-looking statements. The\ninformation contained in this press release is provided as at the date of this\ndocument and is subject to change without notice.\n\nAlvotech Forward Looking Statements\nCertain statements in this communication may be considered “forward-looking\nstatements” within the meaning of the Private Securities Litigation Reform\nAct of 1995, as amended. Forward-looking statements include, for example,\nAlvotech’s expectations regarding competitive advantages, business prospects\nand opportunities including pipeline product development, future plans and\nintentions, regulatory submissions, review and interactions, the potential\napproval and commercial launch of its product candidates, the timing of\nregulatory approval, market launches and financial projections. Such\nforward-looking statements are subject to risks, uncertainties, and other\nfactors which could cause actual results to differ materially from those\nexpressed or implied by such forward-looking statements. These forward-looking\nstatements are based upon estimates and assumptions that, while considered\nreasonable by Alvotech and its management, are inherently uncertain and are\ninherently subject to risks, variability, and contingencies, many of which are\nbeyond Alvotech’s control. Factors that may cause actual results to differ\nmaterially from current expectations include, but are not limited to factors\nset forth in the sections entitled “Risk Factors” and “Cautionary Note\nRegarding Forward-Looking Statements” in documents that Alvotech may from\ntime-to-time file or furnish with the SEC. There may be additional risks that\nAlvotech does not presently know or that Alvotech currently believes are\nimmaterial that could also cause actual results to differ from those contained\nin the forward-looking statements. These forward-looking statements are\nprovided for illustrative purposes only and are not intended to serve as, and\nmust not be relied on by an investor as, a guarantee, assurance, prediction or\ndefinitive statement of a fact or probability. Alvotech does not undertake any\nduty to update these forward-looking statements or to inform the recipient of\nany matters of which any of them becomes aware of which may affect any matter\nreferred to in this communication. Alvotech disclaims any and all liability\nfor any loss or damage (whether foreseeable or not) suffered or incurred by\nany person or entity as a result of anything contained or omitted from this\ncommunication and such liability is expressly disclaimed.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/17a8091d-68a6-47c1-968e-fcced99f1d44)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX7TVmXn-20261014","title":"Alvotech and Advanz Pharma announce first known regulatory submission worldwide for proposed biosimilar to Eylea® 8 mg","author":"Globe Newswire","ticker":"ALVO","created":"2026-10-14T08:30:00.416Z","tickers":["ALVO"],"exchange":"NASDAQ","article_body":"AVT29 submitted to the European Medicines Agency as a line extension to the\nexisting marketing authorization for Mynzepli(®) (aflibercept 2 mg)\n\nHigh-dose aflibercept offers the potential to reduce treatment frequency for\npatients with retinal diseases\n\nREYKJAVIK, Iceland and LONDON, Oct. 14, 2026 (GLOBE NEWSWIRE) -- Alvotech\n(NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the\ndevelopment and manufacture of biosimilar medicines for patients worldwide,\nand Advanz Pharma Holdco Limited (“Advanz Pharma”), a global\npharmaceutical company with a strategic focus on specialty, hospital, and rare\ndisease medicines, today announced the submission of a European regulatory\napplication for AVT29, a proposed biosimilar to Eylea(®) 8 mg (aflibercept\n114.3 mg/mL), which is marketed as Eylea HD(®) in the United States. Based on\npublicly available information, this marks the first regulatory submission\nworldwide for a proposed biosimilar to Eylea(®) 8mg.\n\nThe application was submitted as a line extension to the existing European\nmarketing authorization for Mynzepli(®) (AVT06, 2 mg aflibercept, 40 mg/ mL),\nAlvotech’s biosimilar to Eylea(®) 2 mg.\n\nEylea(®) is used to treat certain retinal diseases through injections\ndirectly into the eye. According to the approved European product information,\nthe 8mg formulation allows treatment intervals of 16 weeks for certain\npatients, compared with the standard eight-week maintenance interval for the\noriginal 2 mg formulation, potentially reducing the frequency of maintenance\ninjections and reducing the treatment burden for patients([)(2)(]).\n\nAccording to publicly reported financial results, the 8mg formulation\naccounted for approximately 57% of combined global Eylea(®) 2mg and 8mg sales\nby value in the second quarter of 2026, up from approximately 30% in the same\nperiod in 2025([)(3)(]).\n\n“To our knowledge, this is the first regulatory submission anywhere in the\nworld for a proposed biosimilar to Eylea 8 mg. This is an important\nachievement for Alvotech and demonstrates the strength of our in-house\ndevelopment capabilities,” said Lisa Graver, Chief Executive Officer of\nAlvotech. “We recognized early the potential of high-dose aflibercept and\ninvested in developing both the 2 mg and 8 mg formulations. Building on the\nEuropean approval of Mynzepli, this milestone positions us at the forefront of\nthe next wave of aflibercept biosimilars and reflects our commitment to\nbroadening access to high-quality biologic medicines.”\n\nSteffen Wagner, Chief Executive Officer of Advanz Pharma, said: “This\nsubmission represents an important milestone in our partnership with Alvotech\nand our shared commitment to improving access to high-quality, affordable\nmedicines. Following the European approval of Mynzepli, we are pleased to be\nadvancing a high-dose formulation that could offer additional treatment\noptions for patients and healthcare professionals across Europe.”\n\nMynzepli(®) received European Commission approval in August 2025 as a\nbiosimilar to Eylea(®) 2 mg (aflibercept 40 mg/mL), in both vial and\nprefilled syringe presentations, for the treatment of various retinal\ndiseases.\n\nUnder the companies’ partnership agreement, Alvotech is responsible for\ndevelopment and commercial supply of AVT06 and AVT29, while Advanz Pharma is\nresponsible for registration and commercialization in Europe. Advanz Pharma\nholds exclusive commercialization rights in Europe, except in Germany and\nFrance, where the rights are semi-exclusive.\n\nFor further information, contact:\n\nAlvotech Media\nBenedikt Stefansson\nSarah MacLeod\nalvotech.media@alvotech.com\n\nAlvotech Investors\nDr. Balaji V Prasad\nBenedikt Stefansson\nMikaela Vilchez\nalvotech.ir@alvotech.com\n\nAdvanz Pharma\nCourtney Baines\ncourtney.baines@advanzpharma.com\n\nAbout AVT06\nAVT06 is a biosimilar to Eylea(®) (aflibercept). Aflibercept binds vascular\nendothelial growth factors (VEGF), inhibiting the binding and activation of\nVEGF receptors, neovascularization, and vascular permeability([)(1]). AVT06\nhas been approved under the brand names Mynzepli(®) (aflibercept) and\nAfiveg(®) (aflibercept) in the European Economic Area, Mynzepli(®)\n(aflibercept) in the United Kingdom and under the name AFLIBERCEPT BS for\nmarketing in Japan.\n\nAbout AVT29\nAVT29 is Alvotech’s proposed biosimilar to Eylea(®) 8 mg (aflibercept), a\nbiologic medicine used to treat retinal diseases that can cause vision loss.\nAVT29 is an investigational product and has not received regulatory approval.\nBiosimilarity has not yet been established by regulatory authorities.\n\nUse of trademarks\nEylea(®) is a registered trademark of Regeneron Pharmaceuticals Inc. and\nBayer AG.\n\nSources\n([1)(])\n(https://www.globenewswire.com/Tracker?data=LPi6n_0C5na9H7AkrMjGufSneRp940rRy3OpW9egj-huxSJnIBcF1Mj_btrtifRvtBsmXYitmvOpYRJLfc4Bsm5ocgYXhzyC453nvF_nFYDHPF5XEUlk1KHiOeGiLggt-zamLZzqZwP6MiFUCmmQJsZZOIJ4xa-My5HGjD6WoVj-8fJMy0MeDRhnRua_VI8p)\nMynzepli\n(https://www.globenewswire.com/Tracker?data=UhHJrgZnmiRWLq27KKtY5J0LrITwBab3V-IOgW8niJf2pOjCTVQVB2igIvBhHfGNJKOVr3XMhf2UuwdzT7hNCcOHdnBn_thrAe3B_mG7cl1kxeJQDLWIg7GocObBXB0EBGE2Ph6PUSZi0Dk4ql7QnC6Y8GlqSk-Xx-jY5wwKGdHSrW69v2Je1AdFw9gLHCBO)(®)\nproduct information\n(https://www.globenewswire.com/Tracker?data=V9yARuVX3M37s827h0g8hcYo0PpFfjsw0G_V9JaScOHcLVC1Sk0spM-7KUQws_AQYi15-1YhKilFD487pAS5cmv9T31uXC8QMZB6a7_R5KRQzx7HZIX-mn2xEnugn-tex5Dly2We-E7V2wqEuLfsQ8hrQkfIwYMxZi_lNh4P_Q3jRkHI12x0VOXSVEitZ3DdNo0OQu-SvnITXk9hl7e5lw==)\n\n([)(2])EMA: Eylea(®) summary of product characteristics\n(https://www.globenewswire.com/Tracker?data=1OkrO-B2VQZgRm_Xypj-hya-wtLXztS9fzPncfqw2Yqk9JxeBGxj5xHIQ8LRfBpYo1GRMCCcVPS5WfGS34IHynfCvjFkhWyzW-ZxUrdhcRFnK_9sKYePPnAFnhDmaLCoAgpSLtAY-oWhwKXM6l1ap3wltUk0EF60aWFVlEMyhE0oLwk_zAGM5xxiO_b4sD2tM8xhJFkOLm8ZqvL-AA4oBkYY_D886F85velQhbPsq18=)\n([)(3)(])Regeneron Pharmaceuticals Inc.: Regeneron Reports Second Quarter 2026\nFinancial and Operating Results\n(https://www.globenewswire.com/Tracker?data=bka-QFVosF7kp3DEK9Fa4A70xhWMZrRmkJpZ6UnJLlnZ1UDZ6xuR1h-v3sEQb3WU7SiwNkfKCUt8VyoYHSEAFL8nqDSwsCx96hvdzUHJeBV6dSire1z0TrqCZsajR8nPAs8tjR7LsPB2mYune9JWgQki6JEzbk9DsKvXh5VVahctIXc-jw-xwAbKvb4dy5CspCCIXU_KdEBDn3VUq7wlih3a4zknd8W2RzJdKtsVTrex_9L1logsbwGuGupjf4RGeMneMQ77qK005p-mSXclnaiJdVcuRpxVEv5jBqnfoZ40pRQXTulWn_nVP-gYr1Eb)\n\nAbout Advanz Pharma\nAdvanz Pharma is a global pharmaceutical company with the purpose to improve\npatients’ lives by providing and enhancing the specialty, hospital, and rare\ndisease medicines they depend on. Our headquarters are in London, UK. We have\ncommercial sales in more than 90 countries globally and have a direct\ncommercial presence in more than 20 countries, including key countries in\nEurope, the US, Canada, and Australia, a Centre of Excellence in Mumbai,\nIndia, as well as an established global distribution and commercialisation\npartner network. Advanz Pharma’s product portfolio and pipeline comprises\ninnovative medicines, specialty generics & biosimilars, and originator brands.\nOur products cover a broad range of therapeutic areas, including hepatology,\ngastroenterology, anti-infectives, critical care, endocrinology, oncology,\nCNS, and, more broadly, rare disease medicines. Our ambition is to be a\npartner of choice for the commercialisation of specialty, hospital, and rare\ndisease medicines in Europe, Canada, and Australia. In line with our ambition,\nwe are partnering with biopharma and development companies to bring medicines\nto patients. For more information, please visit our Website\n(https://www.globenewswire.com/Tracker?data=USOZ7ocyfTbznJBXiYxkLLEMnaI2yFTvL8_S-cWXDyWWuIqZ81mbj8gQIdXdMiZZhcSgFIJamcV-gIK7FsKlaWgpZrvc8utDPmN6EuZrRJ4=)\nor LinkedIn\n(https://www.globenewswire.com/Tracker?data=InH7FFTnK4qdcivE7RzoeTx8pnIJVBCM_DQqoBmOHkG2059F95k98qaEfiXgyBayFDdFQKqawf2qYF8A3jyuG0_5R0zD9A6WMKKIfANJkrRanjUpwl7PQSzQhTPtEM0a).\n\nAbout Alvotech \nAlvotech is a biotechnology company, founded by Robert Wessman, focused solely\non the development and manufacture of biosimilar medicines for patients\nworldwide. Alvotech seeks to be a global leader in the biosimilar space by\ndelivering high-quality, cost-effective products and services, enabled by a\nfully integrated approach and broad in-house capabilities. Five biosimilars\nare already approved and marketed in multiple global markets, including\nbiosimilars to Humira(®) (adalimumab), Stelara(®) (ustekinumab), Simponi(®)\n(golimumab), Eylea(®) (aflibercept) and Prolia(®)/Xgeva(®) (denosumab). The\ncurrent development pipeline includes disclosed biosimilar candidates aimed at\ntreating autoimmune disorders, eye disorders, and cancer. Alvotech has formed\na network of strategic commercial partnerships to provide global reach and\nleverage local expertise in markets that include the United States, Europe,\nJapan, China, and other Asian countries and large parts of South America,\nAfrica and the Middle East. For more information, please visit\nhttps://www.alvotech.com. None of the information on the Alvotech website\nshall be deemed part of this press release.\n\nFor more information, please visit our  website\n(https://www.globenewswire.com/Tracker?data=M-aUNNSbkx2jtY-2J88qPOtG7CHRqeAWlze0kgQXsejyiQqp7Ucr1XiUzP0QSloAlETW5nEAQFyDqXZSTK63_U-S77HMwVbvJd5cwe7-mMoPI6anLSDRBPLQ47yGuAmrYEkrmILmFPkIr8Af1hnA7JE71t6vAh1sQSXLAG-LMeVP7vNzTBiLj2lU8p-dv7V0tULwhOgzYmz_e3HwAXKPqBVoYseeHgcbunnGw9LyFVA=) or\nfollow us on social media on LinkedIn\n(https://www.globenewswire.com/Tracker?data=InH7FFTnK4qdcivE7RzoeXBy_9W2hQf8FlS2E86XT3h99YFkPSK6WeeHee6s_w1J3ZDIaQyWSSsU5j4HNH2jWgDIewHWnDVYWLSdtKRmtMKkb9xO7vPHFTM74v5KXkACg_I3093z4yQ2q8ZU0VziWPLp94gpHiM2YKx2k5etXU2J3zpWVyWsoajFIu7m0mKaYYO8ixPXQIy2r-TfuBJCZfCyC55XoLjFCeIcJ5RSogpDY9QoGS5z1X6MUHJ1n3EA), Facebook\n(https://www.globenewswire.com/Tracker?data=VFSOwwRzP4Tqjr9pKtxIJf9MTt_dJolWr61Az2FuupHxGhk2yP4ALrhs-Szc9u1Sh6y-8aBs9GVjUUAUY5_R_aZikVwKLNuxjPhlVYXobpuyW6ekSs0Ve66r2YKLhIg439IUC5pk2CE4YzucB-9Q2Jrj1iJM0ZaD39F83_kmbUP5vIbae9ZDHXWQjivlr3P0wWmUv6Q3VUDRI4HiJ2dLSU9Z1pShRniklSd5rjSinrHXuubWaS_lRGLX04cBmzH8), Instagram\n(https://www.globenewswire.com/Tracker?data=WIhwAv2-l6JKa4roVbXZGx6g6vrF6VEsfX443zT9cs09Ci-DCncg7JeWLH_Uk1euoAuwmAj3CHLEHtqP-XUb_URD_zVeIIGXtMgMpC8XTUR5RLkGpQisstKpSOyflqFjKObBJB9COG146vKfSt3i0KE1d9IUBhSwjOTvxeP5Jhy0jPuxKD1j9fsHAL7T0AkZkfPm9XinIDtqisdaNDOI_OX9QUm_eoHzV7Pw6ufedUScOdNSdzNL9jrw1v3GwK5U),\nand YouTube\n(https://www.globenewswire.com/Tracker?data=QOFX_du4hN0SWIex9nr3QdBzJA8u2Z9Q5O9KsRddQcG88_9PlIFtorYMB9tCXO5G6kvH7M4g7Kz2LYnJYvDHdi1vgSYpdRQynFtYsMXvwDqQljzH58RiqO8DdgAvTMFq87InLCK2pyJysC0uHCw1Dfb9j2w9PFQvm0xsGPO8KfDmz10B6-k_eEBSptYBQGQxcLE6SDWiQnQz_1uPVR7ccS7VKnHTn8YSJIdAz7uN2FRVFmIO-0D3dkgFIAaDUIBK).\n\nAdvanz Pharma Forward Looking Statements\nCertain statements in this press release are forward-looking statements. These\nstatements may be identified by words such as “anticipate”, \"expectation\",\n\"belief”, \"estimate\", \"plan\", \"target”, “project”, “will”,\n“may”, “should” or \"forecast\" and similar expressions, or by their\ncontext. Although Advanz Pharma believes that these assumptions were\nreasonable when made, by their nature, forward-looking statements involve a\nnumber of risks, uncertainties and assumptions that could cause actual results\nor events to differ materially from those expressed or implied by the\nforward-looking statements. These risks, uncertainties and assumptions could\nadversely affect the outcome and financial consequences of the plans and\nevents described herein. Actual results may differ from those set forth in the\nforward-looking statements as a result of various factors (including, but not\nlimited to, future global economic conditions, changed market conditions\naffecting the industry, intense competition in the markets in which Advanz\nPharma operates, costs of compliance with applicable laws, regulations and\nstandards, diverse political, legal, economic and other conditions affecting\nAdvanz Pharma’s markets, and other factors beyond the control of Advanz\nPharma. Neither Advanz Pharma nor any of its directors, officers, employees,\nadvisors, or any other person is under any obligation to update or keep\ncurrent the information contained in this press release or revise any\nforward-looking statements, whether as a result of new information, future\nevents or otherwise. You should not place undue reliance on forward-looking\nstatements, which speak of the date of this press release. Statements\ncontained in this press release regarding past trends or events should not be\ntaken as a representation that such trends or events will continue in the\nfuture. No obligation is assumed to update any forward-looking statements. The\ninformation contained in this press release is provided as at the date of this\ndocument and is subject to change without notice.\n\nAlvotech Forward Looking Statements\nCertain statements in this communication may be considered “forward-looking\nstatements” within the meaning of the Private Securities Litigation Reform\nAct of 1995, as amended. Forward-looking statements include, for example,\nAlvotech’s expectations regarding competitive advantages, business prospects\nand opportunities including pipeline product development, future plans and\nintentions, regulatory submissions, review and interactions, the potential\napproval and commercial launch of its product candidates, the timing of\nregulatory approval, market launches and financial projections. Such\nforward-looking statements are subject to risks, uncertainties, and other\nfactors which could cause actual results to differ materially from those\nexpressed or implied by such forward-looking statements. These forward-looking\nstatements are based upon estimates and assumptions that, while considered\nreasonable by Alvotech and its management, are inherently uncertain and are\ninherently subject to risks, variability, and contingencies, many of which are\nbeyond Alvotech’s control. Factors that may cause actual results to differ\nmaterially from current expectations include, but are not limited to factors\nset forth in the sections entitled “Risk Factors” and “Cautionary Note\nRegarding Forward-Looking Statements” in documents that Alvotech may from\ntime-to-time file or furnish with the SEC. There may be additional risks that\nAlvotech does not presently know or that Alvotech currently believes are\nimmaterial that could also cause actual results to differ from those contained\nin the forward-looking statements. These forward-looking statements are\nprovided for illustrative purposes only and are not intended to serve as, and\nmust not be relied on by an investor as, a guarantee, assurance, prediction or\ndefinitive statement of a fact or probability. Alvotech does not undertake any\nduty to update these forward-looking statements or to inform the recipient of\nany matters of which any of them becomes aware of which may affect any matter\nreferred to in this communication. Alvotech disclaims any and all liability\nfor any loss or damage (whether foreseeable or not) suffered or incurred by\nany person or entity as a result of anything contained or omitted from this\ncommunication and such liability is expressly disclaimed.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/17a8091d-68a6-47c1-968e-fcced99f1d44)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-14T08:30:00.47768085Z","server_sent_at_ms":1791966600477},"received_at":"2026-10-14T08:30:00.633Z","source_url":null},"analysis":{"id":"156743","press_release_id":"168478","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["AVT29 is investigational and has not received regulatory approval; biosimilarity not yet established","Submission is in Europe only; no US filing for Eylea HD biosimilar announced"],"eventType":"regulatory","narrative":"Alvotech and Advanz Pharma submitted a European regulatory application for AVT29, a proposed biosimilar to Eylea 8 mg, which they describe as the first known regulatory submission worldwide for this high-dose aflibercept product.\n\nThe filing was made as a line extension to the existing European marketing authorization for Mynzepli, Alvotech's approved biosimilar to Eylea 2 mg, potentially accelerating the review path.\n\nThe 8 mg formulation allowed 16-week treatment intervals for certain patients and accounted for roughly 57% of combined global Eylea 2 mg and 8 mg sales by value in Q2 2026, up from about 30% a year earlier.\n\nUnder the partnership, Alvotech develops and supplies AVT29 while Advanz holds exclusive European commercialization rights, except semi-exclusive rights in Germany and France.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"First-mover status on an Eylea 8 mg biosimilar puts Alvotech ahead of the next aflibercept wave targeting a fast-growing high-dose segment."},"keyFigures":{"drugName":"AVT29 (proposed biosimilar to Eylea 8 mg / aflibercept 114.3 mg/mL)","customDimensions":{"extended_treatment_interval":"16 weeks vs 8-week standard for 2 mg formulation","eylea_8mg_share_of_combined_sales_q2_2025":"30%","eylea_8mg_share_of_combined_sales_q2_2026":"57%"}},"quotedText":"To our knowledge, this is the first regulatory submission anywhere in the world for a proposed biosimilar to Eylea 8 mg.","namedEntities":{"people":[{"name":"Lisa Graver","role":"CEO of Alvotech"},{"name":"Steffen Wagner","role":"CEO of Advanz Pharma"},{"name":"Robert Wessman","role":"Founder of Alvotech"}],"products":["AVT29","AVT06","Mynzepli","Eylea 8 mg","Eylea HD","Eylea 2 mg","Afiveg","AFLIBERCEPT BS"],"companies":[{"name":"Alvotech","ticker":"ALVO","relationship":"filer/developer"},{"name":"Advanz Pharma Holdco Limited","relationship":"partner (European commercialization)"},{"name":"Regeneron Pharmaceuticals Inc.","relationship":"originator (Eylea trademark holder)"},{"name":"Bayer AG","relationship":"originator (Eylea trademark holder)"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"First-known regulatory submission worldwide for a proposed biosimilar to Eylea 8 mg, a high-value target representing ~57% of combined Eylea sales in Q2 2026. It is an early-stage milestone (submission, not approval) but strategically meaningful for ALVO's ophthalmology franchise."},"tickerRelevance":{"others":[],"primary":"ALVO"},"globalImportance":35,"audienceRelevance":30,"eventTypeSecondary":["partnership"],"importanceComponents":{"tickerTier":"mid-cap biotech","eventGravity":"first-worldwide regulatory submission, pre-approval","sectorWeight":"biotech regulatory catalyst","marketOpportunity":"8mg aflibercept ~57% of combined Eylea sales"}},"event_type":"regulatory","event_type_secondary":["partnership"],"sentiment":"bullish","material_impact_score":3,"narrative":"Alvotech and Advanz Pharma submitted a European regulatory application for AVT29, a proposed biosimilar to Eylea 8 mg, which they describe as the first known regulatory submission worldwide for this high-dose aflibercept product.\n\nThe filing was made as a line extension to the existing European marketing authorization for Mynzepli, Alvotech's approved biosimilar to Eylea 2 mg, potentially accelerating the review path.\n\nThe 8 mg formulation allowed 16-week treatment intervals for certain patients and accounted for roughly 57% of combined global Eylea 2 mg and 8 mg sales by value in Q2 2026, up from about 30% a year earlier.\n\nUnder the partnership, Alvotech develops and supplies AVT29 while Advanz holds exclusive European commercialization rights, except semi-exclusive rights in Germany and France.","key_figures":{"drugName":"AVT29 (proposed biosimilar to Eylea 8 mg / aflibercept 114.3 mg/mL)","customDimensions":{"extended_treatment_interval":"16 weeks vs 8-week standard for 2 mg formulation","eylea_8mg_share_of_combined_sales_q2_2025":"30%","eylea_8mg_share_of_combined_sales_q2_2026":"57%"}},"named_entities":{"people":[{"name":"Lisa Graver","role":"CEO of Alvotech"},{"name":"Steffen Wagner","role":"CEO of Advanz Pharma"},{"name":"Robert Wessman","role":"Founder of Alvotech"}],"products":["AVT29","AVT06","Mynzepli","Eylea 8 mg","Eylea HD","Eylea 2 mg","Afiveg","AFLIBERCEPT BS"],"companies":[{"name":"Alvotech","ticker":"ALVO","relationship":"filer/developer"},{"name":"Advanz Pharma Holdco Limited","relationship":"partner (European commercialization)"},{"name":"Regeneron Pharmaceuticals Inc.","relationship":"originator (Eylea trademark holder)"},{"name":"Bayer AG","relationship":"originator (Eylea trademark holder)"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-14T08:30:08.190Z","global_importance":35,"audience_relevance":30,"importance_components":{"tickerTier":"mid-cap biotech","eventGravity":"first-worldwide regulatory submission, pre-approval","sectorWeight":"biotech regulatory catalyst","marketOpportunity":"8mg aflibercept ~57% of combined Eylea sales"}},"durationMs":7547,"modelName":"glm-5.3-flashx"}}