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].