Press Release: Novartis: Sandoz will appeal -2-

Institution on the release of the FDA's Biosimilar Action Plan [press

release]. July 18, 2018.

[4] Data on file. Sandoz ZARXIO wholesale acquisition cost (WAC) Data

June 2018 Resource. Sandoz Inc. June 2018.

[5] Cohen, Hillel, et al. Switching Reference Medicines to Biosimilars:

A Systematic Literature Review of Clinical Outcomes. Drugs. March 2018,

Volume 78, Issue 4, pp 463--478 Available at

https://www.ncbi.nlm.nih.gov/pubmed/29500555

https://www.ncbi.nlm.nih.gov/pubmed/29500555.

[6] US Food and Drug Administration. Statement from FDA Commissioner

Scott Gottlieb, M.D., on new actions advancing the agency's biosimilars

policy framework. Available at:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628121.htm

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm628121.htm.

Accessed on January 2019.

[7] Estimate based on calculation of Enbrel(R) US sales in 2016,

available at

https://www.amgen.com/media/news-releases/2017/02/amgen-reports-fourth-quarter-and-full-year-2016-financial-results/

https://www.amgen.com/media/news-releases/2017/02/amgen-reports-fourth-quarter-and-full-year-2016-financial-results/

and Evaluate Pharma estimates for number of patients and annual NET

price per patient. Accessed on February 2019.

[8] The Biosimilars Council. The New Frontier for Improved Access to

Medicines: Biosimilars & Interchangeable Biologic Products. Available

at: :

https://biosimilarscouncil.org/wp-content/uploads/2017/09/Biosimilars-Council-Handbook-09-17.pdf

https://biosimilarscouncil.org/wp-content/uploads/2017/09/Biosimilars-Council-Handbook-09-17.pdf.

[Accessed August 2018]

[9] U.S. Food and Drug Administration. "FDA approves Erelzi, a

biosimilar to Enbrel". Available at:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm518639.htm.

Accessed on February 2019.

# # #

Novartis Media Relations

Central media line: +41 61 324 2200

Email: mailto:media.relations@novartis.com media.relations@novartis.com

Antonio Ligi Eric Althoff

Novartis Global Media Relations Novartis US External Communications

+ 41 61 324 1374 (direct) +1 646 438 4335

+ 41 79 723 3681 (mobile) Email: mailto:eric.althoff@novartis.com eric.althoff@novartis.com

Email: mailto:antonio.ligi@novartis.com antonio.ligi@novartis.com Michelle Bauman

Chris Lewis Sandoz Global Communications

Sandoz Global Communications +1 973 714 8043 (mobile)

+49 174 244 9501 (mobile) Email: mailto:michelle.bauman@sandoz.com michelle.bauman@sandoz.com

Email: mailto:chris.lewis@sandoz.com chris.lewis@sandoz.com

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Novartis Investor Relations

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Email: mailto:investor.relations@novartis.com

investor.relations@novartis.com

Central North America

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(END) Dow Jones Newswires

August 09, 2019 15:46 ET (19:46 GMT)