Core Insights - The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisations for all four presentations of Gobivaz, a biosimilar to Simponi (golimumab) developed by Alvotech in partnership with Advanz Pharma [1][2] Group 1: Product Details - Gobivaz is available in 50 mg/0.5 mL and 100 mg/mL presentations, in both pre-filled syringe and autoinjector formats, targeting conditions such as rheumatoid arthritis, psoriatic arthritis, axial spondylarthritis, ulcerative colitis in adults, and juvenile idiopathic arthritis [2] - The approvals apply across the United Kingdom, enhancing access to this important biologic treatment for immune-mediated diseases [4] Group 2: Company Statements - Alvotech's Chief Scientific and Technical Officer, Joseph McClellan, emphasized that this approval validates the company's integrated development and manufacturing platform for biosimilars [3] - Advanz Pharma's Chief Medical Officer, Nick Warwick, stated that the approvals position the company well to broaden access to Gobivaz for patients and healthcare professionals in the UK [4] Group 3: Partnership Structure - Under the partnership, Alvotech is responsible for the development and commercial supply of Gobivaz, while Advanz Pharma holds the registration and exclusive commercialization rights in Europe and the UK [5] Group 4: Company Background - Alvotech is focused on developing and manufacturing biosimilar medicines globally, with a pipeline that includes eight disclosed biosimilar candidates aimed at treating various conditions [8] - Advanz Pharma specializes in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries and a product portfolio that includes innovative medicines and biosimilars [9]

Core Viewpoint - The FDA has approved Teva Pharmaceutical Industries Ltd. and Alvotech's Selarsdi as an interchangeable biosimilar to Johnson & Johnson's Stelara, expanding treatment options for various inflammatory conditions [1][2]. Group 1: Product Approval and Details - Selarsdi is approved for multiple indications, including adult and pediatric psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis, effective from April 30, 2025 [1]. - The approved presentations of Selarsdi include 45 mg/0.5 mL and 90 mg/mL in prefilled syringes, 45 mg/0.5 mL in vials, and 130 mg/26 mL for intravenous infusion [3]. Group 2: Strategic Partnerships and Market Position - Teva and Alvotech entered a strategic partnership in August 2020 to exclusively commercialize five biosimilar candidates, which was later extended to include additional products [4]. - Teva's recent launches of Selarsdi and another biosimilar, along with a robust pipeline, position the company for strong leadership in the biosimilars market [2]. Group 3: Financial Impact and Stock Performance - Following the news of the approval, TEVA stock increased by 2.10% to $16.53, while ALVO stock rose by 0.67% to $8.22 [5]. Group 4: Future Developments - The FDA has accepted Biologics License Applications for three additional biosimilar candidates developed by Alvotech in partnership with Teva, with goal dates for approval in Q4 2025 [6].