Sandoz makes new investment in biopharmaceuticals in Slovenia

The new investment of USD 3.75 million at the Mengeš site represents a further strengthening of Lek within the global Sandoz biopharmaceutical development and production network. Mengeš is one of the three main biopharmaceutical development and production centers within Sandoz worldwide, and a center of excellence for cell culture and modified protein technology.

The new 430 m2 facility will serve as a global supply point for Sandoz modified proteins. Over the years, Sandoz and its parent company Novartis have invested a total of EUR 45 million in biopharmaceuticals in Slovenia – a clear demonstration of corporate confidence in our knowledge and expertise.

Dr. Violeta Gabrijelčič, Head Biopharmaceuticals at Lek, said: “Following the opening of the production for recombinant technologies ¬– PORT 1 – in 2004, and the Development centre in 2007, one of the key milestones in our history was regulatory approval to manufacture epoetin alfa drug substance in Mengeš at the end of 2009. This achievement is a further contribution to reinforcing Sandoz’s position as the global leader in biosimilars.”

Lek Biopharmaceuticals is the only industrial centre for modern, recombinant technology in Slovenia. There are 150 experts working here (pharmacists, chemists, biotechnologists, microbiologists, biochemists), of whom more than one quarter have a PhD or Masters Degree. We offer these Slovenian experts the chance to work in their home country for a major global pharmaceutical company.

Biosimilars are broadening access to essential high-quality medicines

“Our endeavours in biopharmaceuticals will have an important impact on health systems going forward. Biologics are an increasingly indispensable part of modern medicine, but are very expensive due to demanding research and development. Biosimilars, pioneered by Sandoz, make these vital medicines accessible to more people. We are proud that all three Sandoz biosimilars (human growth hormone somatropin, epoetin, filgrastim) are available to patients in Slovenia, “ said Zvonko Bogdanovski, member of the Lek Board of Management.

Biosimilars offer comparable quality, safety and efficacy to their reference products, at a more affordable price. The introduction of biosimilars has already led to significant savings in the EU. The European Generic Medicines Association (EGA) estimates that a 20% price reduction on five off-patent biopharmaceuticals can save the EU over EUR 1.6 billion per year.

Sandoz human growth hormone somatropin was the first biosimilar ever to be introduced in the EU (in 2006), followed in 2007 by epoetin alfa (anemia), and filgrastim in 2009 (oncology).

Sandoz is now the only company with three biosimilars on the EU market, including Slovenia –and products on three continents – Europe, North America (US and Canada), and Asia (Japan), as well as Australia.

Ameet Mallik, Head Biopharmaceuticals Sandoz, said at the opening ceremony: “The development and production of biopharmaceuticals is extremely complex and challenging. Sandoz has decades of experience in biotechnology, and this has paved the way for us to pioneer the field of biosimilars – affordable, high quality, follow-on biopharmaceuticals, which are at the vanguard of the ongoing biologics revolution, helping to meet the growing needs of governments, payers, physicians, and patients. With three biosimilars already on the market and an unrivalled pipeline, Sandoz and Novartis are determined to continue leading the way forward.”