Core Insights - Alvotech has launched Gobivaz® (golimumab), the first marketed biosimilar to Simponi® worldwide, in Europe, with exclusive commercialization by Advanz Pharma [1][3] - The introduction of Gobivaz in the UK is supported by a National Health Service (NHS) England tender award, enhancing access to biologic treatments for immune-mediated inflammatory diseases [2] - Gobivaz's approval was backed by extensive analytical, pre-clinical, and clinical studies demonstrating its biosimilarity to the reference product, and it is manufactured at Alvotech's facility in Iceland [3] Company Overview - Alvotech is a biotechnology company focused on developing and manufacturing biosimilar medicines globally, aiming to be a leader in the biosimilar market by providing high-quality, cost-effective products [4] - The company has five biosimilars approved and marketed in various global markets, including those for Humira®, Stelara®, Simponi®, Eylea®, and Prolia®/Xgeva®, with a pipeline of nine additional biosimilar candidates targeting various diseases [4] - Alvotech has established strategic commercial partnerships to enhance its global reach and leverage local expertise across markets including the US, Europe, Japan, China, and parts of South America, Africa, and the Middle East [4]

Core Insights - The European Commission has granted marketing authorizations for Gobivaz®, a biosimilar to Simponi® (golimumab), developed by Alvotech in partnership with Advanz Pharma [1][2][3] Group 1: Product Approval - Gobivaz® is approved in two formats: 50 mg/0.5 mL and 100 mg/mL, for treating various conditions including rheumatoid arthritis and juvenile idiopathic arthritis [2][6] - The approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use [2][6] Group 2: Partnership and Market Strategy - The approval of Gobivaz® marks the second biosimilar approved through the partnership between Alvotech and Advanz Pharma, enhancing their commercial presence in Europe [3][4] - Alvotech is responsible for the development and commercial supply of Gobivaz®, while Advanz Pharma holds registration and exclusive commercialization rights in the EEA and the UK [5] Group 3: Clinical Evidence - The EC approval was based on comprehensive evidence, including analytical and clinical data, with positive results from studies comparing AVT05 (Gobivaz®) to Simponi® [6][7] - Alvotech announced positive top-line results from a confirmatory clinical study and a pharmacokinetic study assessing AVT05's efficacy and safety [6][7] Group 4: Company Background - Alvotech focuses on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space with a pipeline of eight disclosed candidates [9][10] - Advanz Pharma specializes in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [11][10]

Core Points - Scott+Scott Attorneys at Law LLP is investigating Alvotech for potentially issuing misleading statements and failing to disclose material information to investors, which may violate federal securities laws [1] - Alvotech develops and manufactures biosimilar medicines, focusing on therapeutic areas such as autoimmune, eye, bone disorders, and cancer [2] - On November 2, 2025, Alvotech received a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AVT05, a biosimilar candidate to Simponi®, indicating deficiencies that must be resolved before approval [3] - Following the FDA's announcement, Alvotech's stock price dropped approximately 34%, closing at $5.03 on November 3, 2025 [3]

Core Insights - Scott+Scott Attorneys at Law LLP is investigating Alvotech for potentially issuing misleading statements and failing to disclose material information to investors, which may violate federal securities laws [1][3] - Alvotech develops and manufactures biosimilar medicines, focusing on therapeutic areas such as autoimmune, eye, bone disorders, and cancer [2] - On November 2, 2025, Alvotech received a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AVT05, a biosimilar candidate to Simponi®, indicating deficiencies that must be resolved before approval [3] - Following the FDA's announcement, Alvotech's stock price dropped approximately 34%, closing at $5.03 on November 3, 2025 [3]

Core Points - Alvotech announced that the FDA issued a complete response letter (CRL) for its Biologics License Application (BLA) for AVT05, a biosimilar candidate to Simponi® (golimumab) [1][2] - The CRL highlighted deficiencies identified during the FDA's pre-license inspection of Alvotech's Reykjavik manufacturing facility, which must be resolved before approval [2] - Alvotech's total revenues for 2025 are now expected to be between $570 million and $600 million, with adjusted EBITDA projected at $130 million to $150 million, reflecting a downward revision due to ongoing investments to address facility issues [5] Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space with a pipeline that includes eight disclosed biosimilar candidates targeting various diseases [6] - The company has established a network of strategic commercial partnerships across multiple regions, including the U.S., Europe, and Asia, to enhance its market reach and leverage local expertise [6]

Core Viewpoint - Alvotech and Advanz Pharma announced a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use recommending approval for Gobivaz®, a biosimilar to Simponi® (golimumab), which is used to treat chronic inflammatory diseases [1][4]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space with a pipeline that includes eight disclosed biosimilar candidates targeting various diseases [9]. - Advanz Pharma is a UK-based global pharmaceutical company specializing in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [11]. Product Details - Gobivaz® is proposed in two formulations: 50 mg/0.5 mL and 100 mg/mL, intended for treating rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, and juvenile idiopathic arthritis [4]. - The product is still under EMA regulatory review, with a final decision pending from the European Commission [4]. Clinical Study Results - Alvotech previously announced positive top-line results from a clinical study comparing the efficacy, safety, and immunogenicity of its biosimilar candidate AVT05 with Simponi® in patients with moderate to severe rheumatoid arthritis [6]. - A pharmacokinetic study also showed positive results for AVT05 compared to Simponi® in healthy adult participants [6]. Strategic Partnership - Alvotech is responsible for the development and commercial supply of Gobivaz®, while Advanz Pharma holds exclusive rights for commercialization in Europe [5].