Swiss pharmaceutical company and global leader in generic pharmaceuticals and biosimilars; spun off from Novartis to become an independent listed entity in October 2023. The Sandoz name traces back to the business founded in Basel in 1886 by Alfred Kern and Edouard Sandoz.
相关临床试验
140
4 进行中
药物批准
60
批准总数
监管机构
2
监管机构数
成立时间
2023
进行中（未招募）
3
2.1%
已完成
125
89.3%
尚未招募
1
0.7%
终止
8
5.7%
撤回
3
2.1%
- Sandoz will hold exclusive global commercialisation rights to a proposed emicizumab biosimilar, excluding Argentina, Uruguay and Paraguay, while mAbxience handles development and manufacturing. - The reference medicine Hemlibra (emicizumab) treats haemophilia A and generated an estimated USD 5.7 billion in global sales, making it the first haemophilia asset in Sandoz's biosimilar pipeline. - The deal lifts the Sandoz biosimilar pipeline to 40 assets and follows earlier agreements with Henlius for up to 10 assets and Samsung Bioepis for up to five. - Haemophilia A is a rare genetic disorder caused by inadequate or defective factor VIII and accounts for roughly 80% of all haemophilia cases, with more than half of patients having the severe form.
- Health Canada has granted marketing authorisation to Sandoz Semaglutide, a generic GLP-1 receptor agonist injection referencing Novo Nordisk's Ozempic, for adults with type 2 diabetes. - The approval covers once-weekly subcutaneous dosing in three strengths across two pen presentations, including 0.25 mg and 0.5 mg pens and a 1 mg pen. - Sandoz frames the move as an access milestone in a Canadian GLP-1 market worth an estimated USD 2.6 billion, with nearly 12 million semaglutide injection pens used annually. - The Canadian authorisation follows FDA acceptance of Sandoz's generic tirzepatide applications and Brazilian approval of Owozy (semaglutide), and Sandoz expects no material 2026 contribution from generic semaglutide launches.
- Health Canada authorized Imuldosa (ustekinumab) on 21 January 2026 as a Stelara biosimilar for Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. - Henlius and Organon received Canadian approval on 24 March 2026 for Bildyos and Tuzemty, denosumab biosimilars referencing Prolia and Xgeva respectively. - Apotex's Denoza and Biocon's Bosaya and Vevzuo added further Canadian denosumab approvals in early April 2026, deepening the competitive field. - As of September 2026, Europe had approved 14 ustekinumab and 15 denosumab biosimilars, while the US had approved 8 and 19 respectively.
- Lupin expects biosimilar turnover of close to $500 million over the next five years, anchored by its recently approved pegfilgrastim biosimilar and upcoming ranibizumab launches. - The company has invested about ₹500 crore in biosimilar manufacturing capacity and plans to raise total investment to roughly ₹700 crore. - Lupin has begun raising external funding for Kaveri Therapeutics, its oncology-focused spin-off housing two specialised oncology programmes, while intending to remain majority shareholder. - Biosimilars of nivolumab, dinutuzumab and pertuzumab are planned for India, alongside existing etanercept biosimilar sales in Europe and Japan through partnerships.
- A judge has found that a Sandoz generic product would infringe patents held by a Johnson & Johnson unit, according to a Law360 report. - The ruling was reported by Law360, which covers legal issues, trends and developments across more than 60 topics, industries, practice areas and jurisdictions. - Law360 publishes over 200 articles daily and maintains a searchable archive of more than 450,000 articles for subscribers.
- Novartis reported that late-stage testing of its del-desiran drug for myotonic dystrophy failed to meet its primary endpoint, marking the company's second drug development setback in as many days. - The failure follows a closely watched setback announced Monday, when experimental cholesterol drug pelacarsen failed to deliver positive results in a late-stage trial. - Novartis shares tumbled sharply, falling 8.8% to 10.9% across European trading, and the news weighed on sentiment across the broader pharmaceutical sector. - The dual setbacks underscore the high-risk nature of late-stage clinical development for the Swiss drugmaker and pressured drugmaker stocks including AstraZeneca and Smith+Nephew.
- Sandoz reported second-quarter net sales of $3.01 billion, a 9% increase year-over-year, narrowly surpassing the $2.99 billion analyst consensus. - Biosimilar net sales rose 22% at constant currencies, building on an 18% first-quarter jump, driven by patent expirations on reference biologics. - North American biosimilar sales surged 47% in the first half of 2026, fueled by launches of bone disease drug Wyost and osteoporosis drug Jubbonti. - The company confirmed its full-year guidance for net sales and core EBITDA while advancing into the GLP-1 market with a first approval in Brazil.
- Sandoz has agreed to pay approximately $450 million to settle antitrust litigation with 43 US states and territories over alleged price-fixing in the generic medicines market. - A separate $28.5 million settlement resolves class-action claims brought by indirect resellers including retail pharmacies, clinics, and hospitals. - The settlements contain no admission of wrongdoing and payments will be spread over seven years starting in 2027, with no impact on 2026 financial guidance. - These agreements resolve all pending class actions and governmental claims, leaving only individual plaintiffs who opted out of class settlements.
- The EPO Boards of Appeal revoked EP 3 288 980, a BMS patent covering anti-PD-1 treatment of PD-L1-positive melanoma, in decision T 0715/24. - The Board ruled that combining a flat-dose regimen with nivolumab monotherapy extended beyond the content of the application as filed. - BMS also lost EP 3 322 731 after withdrawing its appeal, while the basic patent EP 2 161 336 remains protected by SPCs and data exclusivity until end of 2030. - Amgen's nivolumab biosimilar ABP 206 is in phase 3, with Sandoz, Intas and Accord also developing Opdivo biosimilars.
- Pharmaceutical R&D is under structural pressure from patent expirations, rising development costs, regulatory complexity, and increasing shareholder scrutiny, forcing companies to reassess capital allocation and asset prioritization. - A leading PharmaCo's 5R framework increased R&D success rates from approximately 4% to 19%, demonstrating the measurable impact of rigorous, data-driven portfolio prioritization. - Bristol Myers Squibb's institutionalized asset "fast lane" accelerated development timelines through higher company attention, faster committee access, bootcamps, more trial sites, and A-teams. - AI-driven modeling and scenario tools promise better forecasting, but organizations remain uncertain about data maturity, bias risks, and governance implications.
