Management frames the coming years as an unprecedented loss-of-exclusivity wave: medicines worth more than USD 650 billion, about half of them biologics, are expected to lose patent protection over the next decade, with roughly USD 320 billion in biologics losing exclusivity in ten years per company commentary. Sandoz's Bio100 ambition, unveiled at its September 2026 Capital Markets Day, targets a portfolio of more than 100 biosimilars by 2040, up from 13 marketed molecules today, and coverage of about 80% of biosimilar loss-of-exclusivity opportunities from 2035 onwards.
To capture this, Sandoz is investing in in-house capabilities: the approximately USD 300 million Ljubljana facility adding 8,000 litres of drug substance capacity by 2029, a new biosimilar development center, partnerships such as the Henlius deal for up to 10 assets, and FDA-accepted in-house generic tirzepatide applications (29/06/2026) that extend the model into GLP-1s, while confirming full-year 2026 guidance after a strong first half.
Sandoz holds a unique position as the only global pure-play generics and biosimilars company, combining the industry's leading biosimilar pipeline (39 assets, potentially up to 46 after the Henlius expansion) with a high-volume generics business representing about 70% of 2025 net sales. Its pioneering track record - the first biosimilar in Europe (2006) and the first multiple sclerosis biosimilar launch in the US, TYRUKO (November 2025) - underpins deep regulatory and commercial expertise.
Execution strength is visible in H1 2026 results: net sales up 5% at constant currencies to USD 5,761 million, biosimilars at a record 33% of sales, North America biosimilar growth of 47%, and core EBITDA margin expansion to 20.9%, with Europe posting 21 consecutive quarters of growth and the #1 generics position. Vertical integration investments, including the approximately USD 300 million Ljubljana drug substance facility (8,000 litres by 2029) and the Just-Evotec Biologics EU acquisition in Toulouse, strengthen control over development and supply.
Generic medicines are subject to continuous price erosion that partially offsets strong volume growth: H1 2026 volumes grew 10% at constant currencies while net sales grew only 5%, with management citing a one-percentage-point anti-infective B2B headwind. In Europe, off-patent medicines face tender-driven price pressure and regulatory burdens, and Sandoz is litigating the EU Urban Wastewater Treatment Directive's Extended Producer Responsibility scheme, which it argues places disproportionate quaternary-treatment costs on low-priced essential medicines.
The company also carries legacy US generic-medicine litigation, for which it announced further resolution steps on 3 August 2026, and must fund heavy capital investment to execute Bio100. Biosimilar adoption remains policy-dependent, with uptake hinging on procurement design and prescriber incentives that vary by market.
