? European Commission's (EC) approval based on comprehensive data package confirming that Zessly® matches safety, efficacy and quality of reference medicine
? Biosimilars such as Zessly enable earlier patient access to important medicines and positively impact healthcare systems
? Zessly is the third EC approval for a Sandoz biosimilar in 12 months

Holzkirchen, Germany, May 24, 2018 - Sandoz, a Novartis division and the global leader in biosimilars, today announced that the European Commission (EC) has approved Zessly® (infliximab) for use in Europe.

Zessly is approved for use in all indications of the reference medicine*** including rheumatoid arthritis, adult Crohn's disease, pediatric Crohn's disease, adult ulcerative colitis, pediatric ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

"The European Commission approval for Zessly is a key milestone in bringing this important medicine to appropriate patients," said Richard Francis, CEO, Sandoz. "Biosimilars, such as Zessly, help to address a significant unmet need for earlier patient access to biologic medicines and are at the heart of our Sandoz commitment to improving and extending lives."

The EC approval was based on review of a comprehensive development program, including analytical, preclinical and clinical data, which confirmed Zessly matched its reference medicine in terms of safety, efficacy and quality. The clinical Phase III confirmatory study in rheumatoid arthritis (REFLECTIONS B537-02) met its primary endpoint, demonstrating equivalent efficacy of Zessly to the reference medicine as measured by the American College of Rheumatology 20 (ACR20) response at Week 14.[1]

As a Novartis division, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialization. Zessly is the sixth approved biosimilar medicine for Sandoz, with several more major oncology and immunology launches expected globally by 2020.

About Zessly® (infliximab)
Zessly blocks the action of tumor necrosis factor (TNF)-alpha in patients with certain autoimmune diseases in which excess TNF-alpha activity may be harmful or cause onset of disease. By blocking the action of TNF-alpha, infliximab inhibits an underlying cause of inflammation.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "well-positioned," "can," "will," "expected," "commitment," "investigational," "portfolio," etc. etc..

Learn more about biosimilars: https://www.sandoz.com/our-work/biopharmaceuticals?

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References

[1] Cohen, SB. A Randomized, Double-Blind Study Comparing PF-06438179/GP1111, a Potential Infliximab Biosimilar, and Infliximab, Both in Combination with MTX, As Treatment for Patients with Moderate to Severe Active RA Who Have Had an Inadequate Response to MTX Therapy. Available at: http://acrabstracts.org/abstract/a-randomized-double-blind-study-comparing-pf-06438179gp1111-a-potential-infliximab-biosimilar-and-infliximab-both-in-combination-with-mtx-as-treatment-for-patients-with-moderate-to-severe-active/?. Accessed on 20 March 2018.

***Remicade® is marketed by MSD in Europe and is a registered trademark of Janssen Biotech, Inc.

Sandoz acquired infliximab (PF-06438179) development, commercialization and manufacturing rights from Pfizer in February 2016 for the 28 European Union countries plus Norway, Iceland and Liechtenstein that form the European Economic Area (EEA). Under the terms of the divestment, Pfizer retains commercialization and manufacturing rights to infliximab (PF-06438179) in countries outside the EEA.

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