The Novartis subsidiary’s investment in the project is expected to be at least US$400m.
A Memorandum of Understanding (MOU) for the build was signed today at a ceremony in Ljubljana led by Slovenian prime minister, Dr Robert Golob, and Sandoz CEO, Richard Saynor.
Sandoz said the initiative underpins its ambition to drive future growth of biosimilars, and it also represents one of the largest-ever international private-sector investments in Slovenia.
Work on the new plant is set to begin this year, with the new facility scheduled to be fully operational by late 2026.
The site will enable Sandoz to meet growing demand for current and future biosimilars in the mid- to long-term, said Glenn Gerecke, global head of Sandoz Technical Operations. “The location offers us a strong combination of political stability, proximity to our existing European-based production and commercial operations, and competitive costs.”
A Sandoz-created global biosimilar initiative is pushing for improved access to those drugs. The ‘Act4Biosimilars’ organization wants to see increased adoption of biosimilars by at least 30% in over 30 countries by 2030.
Launched last year, Act4Biosimilars aims to increase patient access to biosimilars by targeting ‘four As’: approvability, accessibility, acceptability and affordability.
The initiative is led by a multidisciplinary stakeholder group of patient advocacy leaders, healthcare professionals, biosimilar experts and industry leaders from around the world.
Stand-alone business
In August 2022, Novartis announced that, following a strategic review of the Sandoz generics and biosimilars unit, it would be spun off into a publicly traded, standalone company in the second half of 2023 as part of the parent group’s effort to focus on its patented prescription medicines.
The planned spin-off remains on track said Novartis last month, but it added that Sandoz's core operating income is expected to decline by a "low double digit" percentage in 2023 due to cost inflation and investments to make it a stand-alone business.