Lek Pharmaceuticals, a subsidiary of Sandoz Pharmaceuticals, has initiated the construction of a new high-tech biopharmaceutical production centre in Lendava, Slovenia, to expand its biosimilar production capabilities.
The new facility is the first among three planned for the Lek site in Lendava. It will generate energy products for existing production and support a future centre for producing drug substances for biosimilars, targeting treatments in rheumatology, oncology and immunology.
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Lek entered into a memorandum of understanding (MoU) with the Slovenian government for the construction of the facility in March 2023, committing to an investment of $400m. The investment in the facility is the largest of its kind in Slovenia.
This initial phase of development is part of a broader investment plan to expand production capabilities at the Lendava site.
The groundbreaking on the facility took place in December 2023. The facility’s completion and operational status are anticipated by the end of 2026.
The new facility is projected to generate up to 300 new high-value-added positions.
Location
Lek Pharmaceuticals’ new biosimilar production facility is located at Trimlini 2D, 9220 in the city of Lendava.
The selection of the city for expansion was based on its developmental potential and strategic location near the borders of four countries.
Lek Pharmaceuticals’ biosimilar production facility details
The centre will cover an area of 40,000m (430,556ft²) and include state-of-the-art facilities for biopharmaceutical production and storage.
Designed for end-to-end production, the centre will feature large-scale drug substance manufacturing, cell bank management with cryogenic storage facilities, pilot-scale production utilising digital twin technology and an in-house laboratory for quality control.
The company intends to make the biopharmaceutical production facility one of Europe’s most efficient sites for producing active pharmaceutical ingredients (APIs) for biologics.
The design emphasises environmental sustainability, incorporating advanced technology to minimise energy and resource consumption.
The Lendava site will work in tandem with the Sandoz Biosimilar Technical Development Centre in Ljubljana, Slovenia, which is also set for completion in 2026.
Sandoz’s biosimilar portfolio
Biosimilars, which are derived from living cells, offer cost-effective alternatives for treating diseases not addressable by traditional medications.
Sandoz, a pioneer in the biosimilars market since 1996, has a history of securing regulatory approvals in Europe, Canada, the US and Japan.
The company’s biosimilars portfolio includes treatments for conditions such as chronic skin diseases, bowel diseases, diabetes, arthritis and cancer. It offers more than 50 critical generic antibiotics for different diseases in major areas.
The company’s biosimilar products include Omnitrope, Binocrit, Zarzio/Zarxio, Rixathon and Erelzi, with an additional 24 biosimilars in development.
Marketing commentary on Sandoz
Sandoz, headquartered in Switzerland, is focused on biosimilars and generics. The company specialises in the production of high-quality, affordable medicines following the expiration of original product patents, thereby supporting extensive patient treatments each year.
The company’s broad global portfolio includes about 1,500 quality biosimilar and generic medicines. Sandoz’s biosimilars are available in more than 90 countries globally which provide treatment to more than 800 million patients in a year.
Sandoz was fully spun off from its parent company, Novartis, to become an independent entity in October 2023.
Lek Pharmaceuticals opened its first production facility in Slovenia at its Menges site for drug substances. The Lek facility at the Lendava site comprises two units and employs more than 775 individuals, focusing on the production of anti-infectives and pharmaceutical packaging.
Other facilities of the company in Slovenia include its headquarters in Ljubljana and a manufacturing facility in Prevalje.
