Press Release: Novartis: Sandoz Supplemental -2-

association with TNF-blocker use. Approximately half of the

post-marketing cases of malignancies in children, adolescents, and young

adults receiving TNF blockers were lymphomas; other cases represented a

variety of different malignancies and included rare malignancies usually

associated with immunosuppression and malignancies that are not usually

observed in children and adolescents.

Hypersensitivity Reactions

-- Anaphylaxis or serious allergic reactions have been reported following

administration of adalimumab products. If an anaphylactic or other

serious allergic reaction occurs, immediately discontinue administration

of HYRIMOZ and institute appropriate therapy.

Hepatitis B Virus Reactivation

-- Use of TNF-blockers, including HYRIMOZ, may increase the risk of

reactivation of hepatitis B virus (HBV) in patients who are chronic

carriers. Some cases have been fatal.

-- Evaluate patients at risk for HBV infection for prior evidence of HBV

infection before initiating TNF-blocker therapy.

-- Exercise caution in patients identified as carriers of HBV and closely

monitor during and after Hyrimoz treatment.

-- In patients who develop HBV reactivation, stop HYRIMOZ and initiate

effective anti-viral therapy. Exercise caution when resuming HYRIMOZ

after HBV treatment.

Neurologic Reactions

-- Use of TNF-blocking agents, including adalimumab products, has been

associated with rare cases of new onset or exacerbation of central

nervous system and peripheral demyelinating disease, including multiple

sclerosis (MS), optic neuritis, and Guillain-Barré syndrome.

-- Exercise caution when considering HYRIMOZ for patients with these

disorders; discontinuation of Hyrimoz should be considered if any of

these disorders develop.

Hematological Reactions

-- Rare reports of pancytopenia, including aplastic anemia, have been

reported with TNF-blocking agents. Medically significant cytopenia has

been infrequently reported with adalimumab products.

-- Consider stopping HYRIMOZ if significant hematologic abnormalities occur.

Heart Failure

-- Worsening and new onset congestive heart failure (CHF) has been reported

with TNF-blockers. Cases of worsening CHF have also been observed with

adalimumab products; exercise caution and monitor carefully.

Autoimmunity

-- Treatment with adalimumab products may result in the formation of

autoantibodies and, rarely, in the development of a lupus-like syndrome.

Discontinue treatment if symptoms of a lupus-like syndrome develop.

Immunizations

-- Patients on HYRIMOZ should not receive live vaccines.

-- Pediatric patients, if possible, should be brought up to date with all

immunizations prior to initiating HYRIMOZ therapy.

-- Adalimumab is actively transferred across the placenta during the third

trimester of pregnancy and may affect immune response in the in

utero exposed infant. The safety of administering live or live-attenuated

vaccines in infants exposed to adalimumab products in utero is unknown.

Risks and benefits should be considered prior to vaccinating (live or

live-attenuated) exposed infants.

ADVERSE REACTIONS

The most common adverse reactions (incidence > 10 %): infections (e.g., upper respiratory, sinusitis), injection site reactions, headache and rash.

Please see full Prescribing Information for Hyrimoz.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

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," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that, if approved, such generic or biosimilar products will be approved for all indications included in the reference product's label. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; the particular prescribing preferences of physicians and patients; competition in general, including potential approval of additional generic or biosimilar versions of such products; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; litigation outcomes, including intellectual property disputes or other legal efforts to prevent or limit Sandoz from selling its products; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Sandoz

Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars. Our purpose is to pioneer access for patients by developing and commercializing novel, affordable approaches that address unmet medical needs. Our ambition is to be the world's leading and most valued generics company. Our broad portfolio of high-quality medicines, covering all major therapeutic areas, accounted for 2021 sales of USD 9.6 billion.

Sandoz on social media:

LinkedIn: https://www.linkedin.com/company/sandoz

Twitter: https://twitter.com/sandoz_global

Facebook: https://www.facebook.com/sandozglobal/

Instagram: https://www.instagram.com/sandozglobal

CEO Richard Saynor on LinkedIn: https://www.linkedin.com/in/richard-saynor/

References

1. EMA 2021. Humira(R) EPAR Product Information. Available from:

https://www.ema.europa.eu/en/medicines/human/EPAR/humira. [Accessed June

2022 ]

2. FDA 2021. Humira(R) Highlights of Prescribing Information. Available

from:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125057s417lbl.pdf. [Accessed

June 2022 ]

3. FDA 2015. Summary Review sBLA125057/394. Available from:

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125057Orig1s394SumR.pdf.

[Accessed June 2022 ]

4. EMA 2020. Procedural steps taken and scientific information after the

authorization. Available

from:https://www.ema.europa.eu/en/documents/procedural-steps-after/humira

-epar-procedural-steps-taken-scientific-information-after-authorisation_e

n.pdf. [Accessed June 2022 ]

*Humira is a registered trademark of AbbVie Biotechnology Ltd

# # #

Sandoz Global Communications

Chris Lewis

Sandoz Global Communications

+49 174 244 9501 (mobile)

chris.lewis@sandoz.com

Sandoz US Communications

Leslie Pott

Sandoz US Communications

+1 201 354 0279 (mobile)

leslie.pott@sandoz.com

Novartis Media Relations

E-mail: media.relations@novartis.com

Novartis Investor Relations

Central investor relations line: +41 61 324 7944

E-mail: investor.relations@novartis.com

Central North America

Samir Shah +41 61 324 7944 Sloan Simpson +1 862 778 5052

Nicole Zinsli-Somm +41 79 325 2084

Isabella Zinck +41 61 324 7188

(END) Dow Jones Newswires

July 21, 2022 01:15 ET (05:15 GMT)