Manufacturing of Biosimilars

Biologics, including biosimilars, are changing healthcare systems – improving and extending the lives of millions of patients worldwide.

Novartis has a world-leading portfolio and pipeline of reference biologics and biosimilars. Novartis develops and manufactures these complex molecules to industry-leading quality standards on a large scale, ultimately helping transform patients’ lives:

• 10 sites on three continents
• Over 5,000 employees
• ‘End-to-end’ technical development and manufacturing capabilities, i.e., producing biologics in a single location – from raw materials to finished products.
• Investing in state-of-the art technologies and facilities at global locations that will expand technical capabilities in process development, devices and manufacturing.

Download our brochure "Quality, heritage and excellence through Novartis manufacturing"

Heritage in manufacturing

Novartis – through its Sandoz division – has been at the forefront of the biotechnology revolution for over seven decades, and the pioneer and global leader in biosimilars since a center for the manufacture of penicillin was founded in Kundl, Austria in 1946¹.

Novartis is the global leader in the development and manufacturing of recombinant biotechnological products, producing more than 25 different recombinant proteins for the Sandoz division and other leading companies.

Learn more about our heritage

Biosimilar manufacturing centers of excellence: Producing biologics under one roof

Access to and operation within the Novartis network enables optimal coordination and utilization of facilities. The result is a streamlined transfer of medicines from development to packaging. These ‘end-to-end’ technical capabilities ensure the reliable development and manufacture of industry-leading quality biologics.

Novartis facilities operate in full compliance with Current Good Manufacturing Practice (cGMP) regulations, which are an integral part of the comprehensive quality assurance system for biologics.

The Novartis manufacturing facilities for recombinant medicines are regularly inspected by local and international health authorities, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and many others. Novartis, through the Sandoz Regulatory Department, pioneered the regulatory pathway for biosimilars in the US and EU and has a proven track record of medicine approvals.

Quality at every stage of the process ensures each product fully meets requirements.

The Novartis sites are dedicated to developing and manufacturing industry-leading quality biologics. All sites meet international quality and regulatory requirements and all activities are carried out by highly experienced personnel in a fully cGMP-compliant setting.

Three of these sites are state-of-the-art facilities that develop and manufacture Sandoz biosimilars: Kundl and Schaftenau in Austria, and Mengeš in Slovenia with plans to expand in to other worldwide locations.