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 originator biologics and biosimilars. The forecasted demand for these products is exponential and is projected to grow from approximately USD 162 billion in 2015 to USD 241 billion by 2020¹. The biosimilars market is projected to grow from approximately USD 1 billion in 2015 to USD 14 billion by 2020².

Through its Biologics Technical Development and Manufacturing (BTDM) organization, Novartis develops and manufactures these complex molecules to industry-leading quality standards on a large scale, ultimately helping transform patients’ lives.

About the BTDM organization:

• 10 sites on three continents
• 3,000 employees
• ‘End-to-end’ technical development and manufacturing capabilities, i.e., producing biologics in a single location – from raw materials to finished products.

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 1946.

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

Producing biologics under one roof

By coordinating all functions of production in a single location, Novartis ensures maximum utilization of facilities and a streamlined transfer of products from development to packaging.

These ‘end-to-end’ technical capabilities ensure the reliable development and manufacture of industry-leading quality biologics.

Novartis manufacturing centers of excellence

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 products are inspected and approved 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. The Novartis Regulatory Department pioneered the regulatory pathway for biosimilars in the US and EU and has a proven track record of product approvals.

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

The Novartis BTDM organization has 10 sites 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. Sandoz has plans to invest over USD 1 billion, between 2010 and 2020, in our state-of-the-art biomanufacturing facilities in Schaftenau and Kundl, Austria. This investment will help to ensure that Sandoz biosimilar medicines reach patients and healthcare professionals around the world.