Denosumab

AVT29 submitted to the European Medicines Agency as a line extension to the existing marketing authorization for Mynzepli® (aflibercept 2 mg) High-dose aflibercept offers the potential to reduce treatment frequency for patients with retinal diseases REYKJAVIK, Iceland and LONDON, UK (October 14, 2026) - Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Advanz Pharma Holdco Limited (“Advanz Pharma”), a global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines, today announced the submission of a European regulatory application for AVT29, a proposed biosimilar to Eylea® 8 mg (aflibercept 114.3 mg/mL), which is marketed as Eylea HD® in the United States. Based on publicly available information, this marks the first regulatory submission worldwide for a proposed biosimilar to Eylea® 8mg. The application was submitted as a line extension to the existing European marketing authorization for Mynzepli® (AVT06, 2 mg aflibercept, 40 mg/ mL), Alvotech’s biosimilar to Eylea® 2 mg. Eylea® is used to treat certain retinal diseases through injections directly into the eye. According to the approved European product information, the 8mg formulation allows treatment intervals of 16 weeks for certain patients, compared with the standard eight-week maintenance interval for the original 2 mg formulation, potentially reducing the frequency of maintenance injections and reducing the treatment burden for patients [ 2 ] . According to publicly reported financial results, the 8mg formulation accounted for approximately 57% of combined global Eylea® 2mg and 8mg sales by value in the second quarter of 2026, up from approximately 30% in the same period in 2025 [ 3 ] . “To our knowledge, this is the first regulatory submission anywhere in the world for a proposed biosimilar to Eylea 8 mg. This is an important achievement for Alvotech and demonstrates the strength of our in-house development capabilities,” said Lisa Graver, Chief Executive Officer of Alvotech. “We recognized early the potential of high-dose aflibercept and invested in developing both the 2 mg and 8 mg formulations. Building on the European approval of Mynzepli, this milestone positions us at the forefront of the next wave of aflibercept biosimilars and reflects our commitment to broadening access to high-quality biologic medicines.” Steffen Wagner, Chief Executive Officer of Advanz Pharma, said: “This submission represents an important milestone in our partnership with Alvotech and our shared commitment to improving access to high-quality, affordable medicines. Following the European approval of Mynzepli, we are pleased to be advancing a high-dose formulation that could offer additional treatment options for patients and healthcare professionals across Europe.” Mynzepli® received European Commission approval in August 2025 as a biosimilar to Eylea® 2 mg (aflibercept 40 mg/mL), in both vial and prefilled syringe presentations, for the treatment of various retinal diseases. Under the companies’ partnership agreement, Alvotech is responsible for development and commercial supply of AVT06 and AVT29, while Advanz Pharma is responsible for registration and commercialization in Europe. Advanz Pharma holds exclusive commercialization rights in Europe, except in Germany and France, where the rights are semi-exclusive. For further information, contact: Alvotech Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Alvotech Investors Dr. Balaji V Prasad Benedikt Stefansson Mikaela Vilchez alvotech.ir@alvotech.com Advanz Pharma Courtney Baines courtney.baines@advanzpharma.com About AVT06 AVT06 is a biosimilar to Eylea® (aflibercept). Aflibercept binds vascular endothelial growth factors (VEGF), inhibiting the binding and activation of VEGF receptors, neovascularization, and vascular permeability [ 1] . AVT06 has been approved under the brand names Mynzepli® (aflibercept) and Afiveg® (aflibercept) in the European Economic Area, Mynzepli® (aflibercept) in the United Kingdom and under the name AFLIBERCEPT BS for marketing in Japan. About AVT29 AVT29 is Alvotech’s proposed biosimilar to Eylea® 8 mg (aflibercept), a biologic medicine used to treat retinal diseases that can cause vision loss. AVT29 is an investigational product and has not received regulatory approval. Biosimilarity has not yet been established by regulatory authorities. Use of trademarks Eylea® is a registered trademark of Regeneron Pharmaceuticals Inc. and Bayer AG. Sources [1 ] Mynzepli ® product information [ 2] EMA: Eylea® summary of product characteristics [ 3 ] Regeneron Pharmaceuticals Inc.: Regeneron Reports Second Quarter 2026 Financial and Operating Results About Advanz Pharma Advanz Pharma is a global pharmaceutical company with the purpose to improve patients’ lives by providing and enhancing the specialty, hospital, and rare disease medicines they depend on. Our headquarters are in London, UK. We have commercial sales in more than 90 countries globally and have a direct commercial presence in more than 20 countries, including key countries in Europe, the US, Canada, and Australia, a Centre of Excellence in Mumbai, India, as well as an established global distribution and commercialisation partner network. Advanz Pharma’s product portfolio and pipeline comprises innovative medicines, specialty generics & biosimilars, and originator brands. Our products cover a broad range of therapeutic areas, including hepatology, gastroenterology, anti-infectives, critical care, endocrinology, oncology, CNS, and, more broadly, rare disease medicines. Our ambition is to be a partner of choice for the commercialisation of specialty, hospital, and rare disease medicines in Europe, Canada, and Australia. In line with our ambition, we are partnering with biopharma and development companies to bring medicines to patients. For more information, please visit our Website or LinkedIn . About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our website or follow us on social media on LinkedIn , Facebook , Instagram , and YouTube . Advanz Pharma Forward Looking Statements Certain statements in this press release are forward-looking statements. These statements may be identified by words such as “anticipate”, "expectation", "belief', "estimate", "plan", "target”, “project”, “will”, “may”, “should” or "forecast" and similar expressions, or by their context. Although Advanz Pharma believes that these assumptions were reasonable when made, by their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial consequences of the plans and events described herein. Actual results may differ from those set forth in the forward-looking statements as a result of various factors (including, but not limited to, future global economic conditions, changed market conditions affecting the industry, intense competition in the markets in which Advanz Pharma operates, costs of compliance with applicable laws, regulations and standards, diverse political, legal, economic and other conditions affecting Advanz Pharma’s markets, and other factors beyond the control of Advanz Pharma. Neither Advanz Pharma nor any of its directors, officers, employees, advisors, or any other person is under any obligation to update or keep current the information contained in this press release or revise any forward-looking statements, whether as a result of new information, future events or otherwise. You should not place undue reliance on forward-looking statements, which speak of the date of this press release. Statements contained in this press release regarding past trends or events should not be taken as a representation that such trends or events will continue in the future. No obligation is assumed to update any forward-looking statements. The information contained in this press release is provided as at the date of this document and is subject to change without notice. Alvotech Forward Looking Statements Certain statements in this communication may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements include, for example, Alvotech’s expectations regarding competitive advantages, business prospects and opportunities including pipeline product development, future plans and intentions, regulatory submissions, review and interactions, the potential approval and commercial launch of its product candidates, the timing of regulatory approval, market launches and financial projections. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Alvotech and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Alvotech’s control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to factors set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in documents that Alvotech may from time-to-time furnish with the SEC. There may be additional risks that Alvotech does not presently know or that Alvotech currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Alvotech does not undertake any duty to update these forward-looking statements or to inform the recipient of any matters of which any of them becomes aware of which may affect any matter referred to in this communication. Alvotech disclaims any and all liability for any loss or damage (whether foreseeable or not) suffered or incurred by any person or entity as a result of anything contained or omitted from this communication and such liability is expressly disclaimed.

FILKRI is available with a permanent Q-code, standardizing the billing and reimbursement process across all sites of care. RALEIGH, N.C. , Oct. 12, 2026 /PRNewswire/ -- Accord BioPharma , Inc., the specialty division of Intas Pharmaceuticals, Ltd. , focused on the development of oncology, immunology, and central nervous system (CNS) therapies, announced today the U.S. commercial launch of FILKRI™(filgrastim-laha), a biosimilar to Neupogen® (filgrastim). FDA-approved in January 2026, FILKRI represents Accord BioPharma's continued expansion into oncology supportive care and furthers the company's goal to bring 20 biosimilars to the U.S. market by 2030. 1 FILKRI is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; to reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML); to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation; to reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia; and to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome). FILKRI is available in 300 mcg/0.5 mL and 480 mcg/0.8 mL prefilled syringe presentations, with pack sizes of one or 10 prefilled syringes per carton. 1 The addition of FILKRI expands Accord BioPharma's granulocyte colony-stimulating factor (G-CSF) portfolio, giving U.S. physicians access to both short- and long-acting treatment options through FILKRI and UDENYCA ® (pegfilgrastim-cbqv). These options help meet the individual needs of patients undergoing chemotherapy and their healthcare providers. 2 FILKRI will be manufactured end to end by Accord BioPharma's parent entity, Intas, and has been assigned a permanent Q-code (Q5172) by the U.S. Centers for Medicare & Medicaid Services (CMS), effective October 1, which will standardize the billing and reimbursement process across all sites of care. "The commercial launch of FILKRI with a permanent Q-code from day one is a significant milestone for Accord BioPharma and for cancer patients across the United States," said Chrys Kokino, President of Accord North America. "Having a permanent Q-code will simplify billing and streamline reimbursement, making it more timely and reliable for physicians treating patients." Addressing Critical Patient Needs in Neutropenia Management As a G-CSF, FILKRI is indicated for use across several clinical settings in which neutropenia or its complications may occur, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation. Neutropenia is a condition characterized by lower-than-normal levels of neutrophils, a type of white blood cell that helps the body fight infections. Cancer treatments, including chemotherapy, can damage neutrophils or the bone marrow that produces them. 3 "With FILKRI, alongside our established UDENYCA pegfilgrastim franchise, Accord now offers physicians the choice between long-acting and short-acting biosimilar G-CSF treatments to suit their clinical needs and preferences," Kokino added. "This demonstrates our deep commitment to oncology supportive care and positions us as a comprehensive partner for the oncology community." Filgrastim biosimilars have become well established in the U.S. market, accounting for approximately 77% of filgrastim market share as of the fourth quarter of 2025. 4 Expanding Access Through Competitive Pricing and Patient Support Through AccordCares®, a dedicated patient support program, the company is launching FILKRI with comprehensive patient resources, including benefits investigation and co-pay assistance, designed to connect patients to the information and resources they need, building on the proven foundation established with UDENYCA. "At Accord, we believe that cost shouldn't prevent patients from receiving the cancer care they need," said Nuvan Dassanaike, Senior Vice President, Digital and Marketing Strategy & Operations, Accord BioPharma. "With FILKRI, we're continuing to build on our track record of bringing high-quality biosimilars to market that provide physicians more choice and can make a real difference in patient care and patient affordability. The permanent Q-code further enhances our ability to expand patient access from launch." Building on Proven Leadership in Oncology Supportive Care "The launch of FILKRI in the United States demonstrates our unwavering commitment to building a comprehensive oncology supportive care portfolio that addresses urgent medical needs," said Binish Chudgar, Chairman and Managing Director of Intas Pharmaceuticals. "With the support of Intas, an established global leader with nearly five decades of experience, Accord BioPharma is transforming the conventional treatment landscape by introducing biosimilars to the U.S. market. As our presence in the biosimilar market continues to grow, so does our commitment to offering high-quality, affordable alternatives to reference drugs, so that more patients can access the treatments they need." FDA approval of FILKRI was based on data demonstrating that FILKRI is highly similar to Neupogen, with no clinically meaningful differences. 1 IMPORTANT SAFETY INFORMATION FILKRI is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors (G-CSFs) such as filgrastim or pegfilgrastim products. Splenic Rupture: Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture. Acute Respiratory Distress Syndrome (ARDS): ARDS has been reported in patients receiving filgrastim products . Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS . Discontinue FILKRI in patients with ARDS. Serious Allergic Reactions: Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products . The majority of reported events occurred upon initial exposure . Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment . Permanently discontinue FILKRI in patients with serious allergic reactions. Sickle Cell Disorders: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products . Discontinue FILKRI if sickle cell crisis occurs. Glomerulonephritis: Has occurred in patients receiving filgrastim products . Diagnoses were based on azotemia, hematuria, proteinuria, and renal biopsy . Generally, events resolved after dose reduction or discontinuation of filgrastim products . If causality is likely, consider dose-reduction or interruption of FILKRI. Alveolar Hemorrhage and Hemoptysis: Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization, have been reported in FILKRI-treated healthy donors undergoing peripheral blood progenitor cell (PBPC) collection mobilization . Hemoptysis resolved with discontinuation of filgrastim products. The use of FILKRI for PBPC mobilization in healthy donors is not an approved indication. Capillary Leak Syndrome (CLS): CLS has been reported after G-CSF administration, including filgrastim products and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity, and may be life-threatening if treatment is delayed . Patients with symptoms should be closely monitored and receive appropriate treatment. Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Patients with Severe Chronic Neutropenia (SCN ): Confirm the diagnosis of SCN before initiating FILKRI therapy. MDS and AML have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with filgrastim products for SCN. Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim administration in patients with abnormal cytogenetics or MDS are unknown. Monitor patients for signs and symptoms of MDS/AML in these settings. If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing FILKRI should be carefully considered. Patients with Breast and Lung Cancer : MDS and AML have been associated with the use of filgrastim products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings. Thrombocytopenia: Thrombocytopenia has been reported in patients receiving filgrastim products. Monitor platelet counts. Leukocytosis: Patients with Cancer Receiving Myelosuppressive Chemotherapy : White blood cell counts ≥ 100,000/mm 3 were observed in about 2% of patients who received filgrastim products at dosages above 5 mcg/kg/day. Discontinue FILKRI if the absolute neutrophil count (ANC) surpasses 10,000/mm 3 after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy with FILKRI. Discontinuation of filgrastim therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days‚ with a return to pretreatment levels in 1 to 7 days. Cutaneous Vasculitis: Moderate or severe cases of cutaneous vasculitis has been reported in patients treated with filgrastim products . Most reports involved patients with SCN receiving long-term filgrastim therapy . Hold FILKRI therapy in patients with cutaneous vasculitis . FILKRI dose may be reduced when the symptoms resolve and the ANC has decreased. Potential Effect on Malignant Cells: FILKRI is a growth factor that primarily stimulates neutrophils. The granulocyte colony-stimulating factor (G-CSF) receptor through which FILKRI acts has also been found on tumor cell lines. The possibility that FILKRI acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established. Simultaneous Use with Chemotherapy and Radiation Not Recommended: The safety and efficacy of FILKRI given simultaneously with cytotoxic chemotherapy and radiation have not been established . Do not use FILKRI 24 hours before or after administration of cytotoxic chemotherapy . The safety and efficacy of FILKRI have not been evaluated in patients receiving concurrent radiation therapy . Avoid the simultaneous use of FILKRI with chemotherapy and radiation therapy. Nuclear Imaging: Increased hematopoietic activity of the bone marrow has been associated with transient positive bone-imaging changes on nuclear imaging. Aortitis: Aortitis has been reported in patients receiving filgrastim products . It may occur as early as the first week after start of therapy . Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count) . Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue FILKRI if aortitis is suspected. The most common adverse reactions in patients: with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥ 5% difference in incidence compared to placebo) are pyrexia, pain, rash, cough, and dyspnea with AML (≥ 2% difference in incidence) are pain, epistaxis and rash with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT (≥ 5% difference in incidence) is rash with severe chronic neutropenia (SCN) (≥ 5% difference in incidence) are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia INDICATIONS FILKRI is a leukocyte growth factor indicated to: Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) Reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome) For more information, please see the full Prescribing Information . About Accord BioPharma Accord BioPharma, Inc. is the U.S. specialty division of Intas Pharmaceuticals, Ltd., one of the world's most experienced biosimilar developers. Focused on the therapeutic areas of oncology, immunology, and CNS, Accord BioPharma is committed to expanding patient access to high-quality, affordable biologic therapies. The company's FDA-approved commercial portfolio includes UDENYCA® (pegfilgrastim-cbqv) – a biosimilar to NEULASTA® (pegfilgrastim); FILKRI™ (filgrastim-laha) – a biosimilar to NEUPOGEN® (filgrastim); IMULDOSA® (ustekinumab-srlf) – a biosimilar to STELARA® (ustekinumab); HERCESSI™ (trastuzumab-strf) – a biosimilar to HERCEPTIN® (trastuzumab); OSVYRTI® (denosumab-desu) – a biosimilar to Prolia® (denosumab); JUBEREQ® (denosumab-desu) – a biosimilar to Xgeva® (denosumab); ENNUMO™ (pegfilgrastim-pccg) – a biosimilar to NEULASTA® (pegfilgrastim); and CAMCEVI® (leuprolide mesylate) injectable emulsion. Accord BioPharma has received FDA approval on additional products including IMMGOLIS™ (golimumab-sldi) – a biosimilar to Simponi® (golimumab), and IMMGOLIS INTRI™ (golimumab-sldi) – a biosimilar to Simponi Aria® (golimumab). The company's strategic goal is to launch 20 biosimilar products in the U.S. by 2030. For more information, visit . References: FILKRI (filgrastim-laha) injection. Prescribing Information. Accord BioPharma. UDENYCA Prescribing Information. Coherus BioSciences. Cleveland Clinic. Neutropenia. Updated June 9, 2022. Accessed October 2, 2026. . Samsung Bioepis. Biosimilar Market Report . 13th ed., Q2 2026. All trademarks, logos and brand names are the property of their respective owners. Contact: abipr@accordhealthcare.com View original content to download multimedia: SOURCE Accord BioPharma