Lek Pharmaceuticals, a Slovenia-based pharmaceutical company and a part of the generics producer Sandoz, built a state-of-the-art biosimilar technical development centre in Ljubljana, Slovenia, to support the growth of its biosimilar plans in future.
The centre strengthens Sandoz’s capabilities to develop end-to-end drug substances and drug products of biosimilars. It helps the company meet the rapidly rising demand for biosimilars worldwide.
Recommended Buyers Guides
Announced in July 2023, the project broke ground in April 2024 and involved an investment of $99m.
The new facility was inaugurated in June 2026 and generated approximately 200 new jobs.
Location of Sandoz’s biosimilar technical development facility
The Sandoz-owned biosimilar technical development centre islocated at Lek’s existing site in Ljubljana.
Slovenia offers a pool of highly experienced pharmaceutical professionals and an ecosystem with academia and research institutions, making it an excellent choice for expanding biosimilar development capabilities.
The new facility, along with the existing Sandoz development centre in Ljubljana, transformed the site into a primary global development hub for Sandoz, focusing on the advancement of generic and biosimilar products.
The site also hosts aseptic production facilities alongside other key Lek business and support functions.
Notably, the Ljubljana plant is the first of Sandoz’s $1.1bn investment in Slovenia aimed at establishing a fully integrated, in-house European hub for biosimilar development and manufacturing. It complements the company’s new biologics manufacturing plant in Lendava and the sterile production and packaging facility in Brnik.
The facility is also fully embedded within the company’s wider development network, linking with the bioanalytical and bioassay labs in Holzkirchen, Germany, and the device development capability based in Cambridge, UK.
Sandoz biosimilar technical development centre details
The 10,000m² (107,639ft²) biosimilars development centre harnesses cutting-edge scientific and technological capabilities to enable fully integrated drug substance and drug product development, supported by sophisticated analytics and data science.
The facility’sscope spans the entire development life cycle, including cell line development, bioprocess optimisation, drug product formulation, and process analytical science.
The centre was constructed to high energy-efficiency standards using sustainable materials, and its environmental impact has been assessed as low.
Sandoz’s biosimilars
Sandoz has a wide array of biosimilars in its pipeline and portfolio. The company’s technical development expertise covers various stages, starting from genetic engineering of the cell line, through the design and scaling up of the bioprocess, drug substance purification process, and stable formulation, until the establishment of a robust manufacturing process for the final drug product.
To ensure biosimilarity to reference medicine, the development process is supported by 40 different evaluation techniques and more than 100 measures of function and structure.
The company’s biosimilar portfolio includes Omnitrope® (somatropin) in endocrinology, Rixathon® (rituximab), Erelzi® (etanercept), Zessly® (infliximab), Hyrimoz® (adalimumab), and Pyzchiva® (ustekinumab) in immunology, along with Binocrit® (epoetin alfa), Zarzio®/Zarxio® (filgrastim), Ziextenzo® (pegfilgrastim), and Wyost®/Jubbonti® (denosumab) in oncology.
Additionally, the portfolio includes Cimerli® (ranibizumab) and Afqlir® (aflibercept) in ophthalmology, and Tyruko® (natalizumab) in neurology.
Furthermore, the company is working in collaboration with several companies such as Bio-Thera Solutions, Polpharma Biologics, and Biocon to expand its biosimilar portfolio.
Marketing commentary on Sandoz
Sandoz, a division of Swiss healthcare company Novartis, manages the end-to-end production of various marketed biosimilars using state-of-the-art biomanufacturing facilities to ensure high standards of quality and consistency in the manufacturing process.
The company boasts extensive experience in the regulatory domain that is essential for ensuring the safety and efficacy of biosimilars, with 13 approved biosimilars available in approximately 100 countries across the world.
Sandoz has a development pipeline of up to 36 additional candidates spanning major therapeutic fields such as oncology, immunology, neurology, ophthalmology, and endocrinology.
