공시 • Jul 01
Sandoz Group AG Receives US FDA File Acceptances for Generic Tirzepatide Autoinjector Applications Sandoz Group AG received US FDA file acceptances for generic tirzepatide autoinjector applications. Proposed generic tirzepatide was developed in-house by Sandoz. Applications address same indications covered by reference medicines, including type-2 diabetes and weight management. The ANDAs seek approval for an in-house Sandoz generic version of the tirzepatide autoinjector, a generic gastric inhibitory polypeptide receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. Both applications, which were filed under the FDA's generic pathway, address all indications of the reference medicines, Mounjaro and Zepbound. For Mounjaro, this would be as an adjunct to diet and exercise to improve glycemic control in adults and paediatric patients 10 years of age and older with type 2 diabetes mellitus. For Zepbound, this would be in combination with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in obese or overweight adults in the presence of at least one weight-related comorbid condition and to treat moderate to severe obstructive sleep apnea (OSA) in adults with obesity for weight management. Subject to FDA approval, Sandoz tirzepatide could be one of the first generic tirzepatide products available for patients in the US on market formation. Generic tirzepatide was developed in-house at Sandoz, combining the Company's expertise in small molecule and device development with its biosimilar expertise for advanced techniques. The GLP-1 treatment area represents a long-term market opportunity, complementing the broader growth outlook for biosimilar and generic medicines. Reference medicines with a combined value of more than USD 650 billion are expected to lose patent protection over the next decade. Sandoz is developing a competitive GLP-1 pipeline across key global markets, addressing each opportunity with a mix of internal capabilities and strategic external partnerships across development and manufacturing. Sandoz is committed to helping millions of patients access critical and potentially life-changing medicines sustainably and affordably, with a leading global portfolio comprising 1,300 quality generics and a further 400 generic assets in various stages of development. 공시 • May 16
Sandoz Group AG Confirms European Commission Approval for Biosimilars Bysumlog® (Insulin Lispro) and Dazparda® (Insulin Aspart), Strengthening Position in Diabetes Sandoz Group AG confirms that the European Commission has granted marketing authorisation for Bysumlog (insulin lispro) and Dazparda (insulin aspart). The two biosimilar insulins, for injection in prefilled pens, are developed by Gan & Lee Pharmaceuticals. Bysumlog is approved for the treatment and initial stabilisation of diabetes mellitus in adults and children1, while Dazparda is approved for the treatment of diabetes mellitus in adults, adolescents and children aged one year or more . Both biosimilar insulins have equivalent efficacy and comparable safety to their respective reference medicines, Humalog® and NovoRapid® . Following these approvals, Bysumlog and Dazparda have the potential to increase competition, improve affordability and expand access to insulin treatment options for millions of people living with diabetes across Europe. Diabetes is a chronic condition that occurs when either the pancreas does not produce enough insulin, a hormone that regulates blood glucose, or when the body cannot effectively use the insulin it produces. The disease and its complications can cause blindness, kidney failure, heart attacks, stroke and lower-limb amputation in some patients . An estimated 66 million adults aged 20–79 in Europe live with diabetes and this is projected to rise by 10% to 72 million by 2050, with related healthcare expenditure approaching USD 200 billion . Sandoz entered into an agreement with Gan & Lee in December 2018 to commercialise biosimilar versions of the insulins aspart, lispro and glargine. Under the terms of the agreement, Sandoz will commercialise in Europe and other key territories around the world, while Gan & Lee is responsible for development, manufacturing and supply. The approvals contribute to the continued Sandoz leadership and pioneering legacy in biosimilars, dating back to the introduction of the first biosimilar in 2006. They underscore the company’s commitment to help millions of patients access biologic medicines sustainably and affordably through a global portfolio of 13 biosimilars, supported by an industry-leading pipeline. They further strengthen the Sandoz position in diabetes, while representing another step towards the overall strategic objective of capitalising on a projected approximately USD 320 billion biosimilar market opportunity over the next 10 years . Board Change • May 14
High number of new and inexperienced directors There are 9 new directors who have joined the board in the last 3 years. The company's board is composed of: 9 new directors. 1 experienced director. No highly experienced directors. Independent Non-Executive Chairman Gilbert Ghostine is the most experienced director on the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. 
