Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules
FDA approves biosimilar Pyzchiva® (ustekinumab-ttwe), to be commercialized by
Sandoz in US

  * Pyzchiva® (ustekinumab-ttwe) is approved by FDA for all indications of
    reference medicine

* FDA granted provisional determination for interchangeability designation for

    Pyzchiva®
  * Extends Sandoz immunology portfolio and further strengthens biosimilar
    position
  * Expected to be among first wave of ustekinumab biosimilars to launch in US

Basel, July 1, 2024 - Sandoz, the global leader in generic and biosimilar
medicines, today announced that the US Food and Drug Administration (FDA) has
approved biosimilar Pyzchiva®* (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-
filled syringes for subcutaneous injection and 130 mg/26 mL (5 mg/mL) single-
dose vial for intravenous infusion. Developed by Samsung Bioepis Co., Ltd, it is
approved for all indications of its reference medicine and will be
commercialized by Sandoz in the US. In addition, the FDA provisionally
determined that Pyzchiva® would be interchangeable with the reference medicine
as it is currently subject to an unexpired period of exclusivity for the first
interchangeable biosimilar biological products.
Sandoz intends to launch Pyzchiva® in the US in February 2025, in accordance
with the settlement and license agreement with Janssen Biotech Inc. previously
announced by Samsung Bioepis Co., Ltd. Pyzchiva® is expected to be among the
first wave of ustekinumab biosimilars to launch in the US.
Claire D'Abreu-Hayling, Chief Scientific Officer, Sandoz, said: "This approval
reflects our dedication to ensuring high-quality treatments are universally
accessible. By further expanding our immunology portfolio with affordable
biosimilar alternatives, we continue to make significant strides towards
achieving our goal of delivering life-changing medicines to the patients who
need them."
Pyzchiva® is a key biosimilar value driver for the company over the mid-term,
and this approval is a major step in advancing the Sandoz growth strategy by
extending the US immunology portfolio.
Pyzchiva® is approved by the FDA for all indications of the reference medicine
Stelara®(?) (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist,(1)
including to treat adult patients with moderate to severe plaque psoriasis,
active psoriatic arthritis, moderately to severely active Crohn's disease and
moderately to severely active ulcerative colitis, as well as pediatric patients
with moderate to severe plaque psoriasis and active psoriatic arthritis.(2)
Leah M. Howard, J.D., President and CEO of the National Psoriasis Foundation,
said: "Systemic medications like biologics are a key treatment option for many
people to manage symptoms of psoriasis and psoriatic arthritis. Unfortunately,
barriers to care, including costs, often prevent patients from getting the drug
they are prescribed. Psoriatic disease is lifelong and chronic, leading to long-
term treatment costs. Having more FDA-approved options can help make appropriate
healthcare more affordable."
Plaque psoriasis is the most common form of psoriasis, affecting approximately
80% to 90% of patients.(3)
The FDA granted approval to Samsung Bioepis based on the totality of the
evidence, including robust clinical studies confirming that Pyzchiva® has
equivalent efficacy and comparable safety as its reference medicine.
Sandoz entered into a development and commercialization agreement for biosimilar
ustekinumab with Samsung Bioepis in September 2023. Under the terms of the
agreement, Sandoz has the right to commercialize Pyzchiva® in the US, Canada,
the European Economic Area (EEA), Switzerland and the UK. Samsung Bioepis
remains responsible for development, registration, intellectual property,
manufacturing and supply.
*Pyzchiva® is a trademark of Samsung Bioepis Co. Ltd.
(?)Stelara® is a registered trademark of JOHNSON & JOHNSON (USA).
INDICATIONS
PYZCHIVA (ustekinumab-ttwe) is indicated for the treatment of patients 6 years
or older with moderate to severe plaque psoriasis who are candidates for
phototherapy or systemic therapy, patients 6 years or older with active
psoriatic arthritis, adult patients with moderately to severely active Crohn's
disease, adult patients with moderately to severely active ulcerative colitis.
CONTRAINDICATIONS: Clinically significant hypersensitivity to ustekinumab or to
any of the excipients.
WARNINGS AND PRECAUTIONS: Infections: Serious infections have occurred. Avoid
starting PYZCHIVA during any clinically important active infection. If a serious
infection or clinically significant infection develops, discontinue PYZCHIVA
until the infection resolves. Theoretical Risk for Particular Infections:
Serious infections from mycobacteria, salmonella and Bacillus Calmette-Guerin
(BCG) vaccinations have been reported in patients genetically deficient in IL-
12/IL-23. Consider diagnostic tests for these infections as dictated by clinical
circumstances. Tuberculosis (TB): Evaluate patients for TB prior to initiating
treatment with PYZCHIVA. Initiate treatment of latent TB before administering
PYZCHIVA. Malignancies: Ustekinumab products may increase risk of malignancy.
The safety of ustekinumab products in patients with a history of or a known
malignancy has not been evaluated. Hypersensitivity Reactions: If an
anaphylactic or other clinically significant hypersensitivity reaction occurs,
institute appropriate therapy and discontinue PYZCHIVA. Posterior Reversible
Encephalopathy Syndrome (PRES): If PRES is suspected, treat promptly and
discontinue PYZCHIVA.
Immunizations: Avoid use of live vaccines in patients during treatment with
PYZCHIVA. Noninfectious Pneumonia: Cases of interstitial pneumonia, eosinophilic
pneumonia and cryptogenic organizing pneumonia have been reported during post-
approval use of ustekinumab products. If diagnosis is confirmed, discontinue
PYZCHIVA and institute appropriate treatment.
ADVERSE REACTIONS: Most common adverse reactions are Psoriasis (>=3%):
nasopharyngitis, upper respiratory tract infection, headache, and fatigue.
Crohn's Disease, induction (>=3%): vomiting. Crohn's Disease, maintenance (>=3%):
nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic
infection, bronchitis, pruritus, urinary tract infection, and sinusitis.
Ulcerative colitis, induction (>=3%): nasopharyngitis. Ulcerative colitis,
maintenance (>=3%): nasopharyngitis, headache, abdominal pain, influenza, fever,
diarrhea, sinusitis, fatigue, and nausea.
This is not the complete list of all the safety information for PYZCHIVA. Please
see full Prescribing Information
(https://prod.cms.us.sandoz.com/sites/spare37_sandoz_com/files/Media%20Documents
/BLA%20761373%20and%20BLA%20761425%20PI%20MG%20and%20IFU.pdf) for PYZCHIVA.
Disclaimer
This Media Release contains forward-looking statements, which offer no guarantee
with regard to future performance. These statements are made on the basis of
management's views and assumptions regarding future events and business
performance at the time the statements are made. They are subject to risks and
uncertainties including, but not confined to, future global economic conditions,
exchange rates, legal provisions, market conditions, activities by competitors
and other factors outside of the control of Sandoz. Should one or more of these
risks or uncertainties materialize or should underlying assumptions prove
incorrect, actual outcomes may vary materially from those forecasted or
expected. Each forward-looking statement speaks only as of the date of the
particular statement, and Sandoz undertakes no obligation to publicly update or
revise any forward-looking statements, except as required by law.
References
1. Janssen Pharmaceuticals. Stelara(®) (Ustekinumab): Prescribing Information.
Available at: https://www.janssenlabels.com/package-insert/product-
monograph/prescribing-information/STELARA-pi.pdf (Last accessed: June 2024)
2. Pyzchiva(®). Prescribing Information. Available at: BLA 761373 and BLA
761425 PI MG and IFU.pdf (sandoz.com)
(https://prod.cms.us.sandoz.com/sites/spare37_sandoz_com/files/Media%20Documents
/BLA%20761373%20and%20BLA%20761425%20PI%20MG%20and%20IFU.pdf) (Last accessed:
June 2024)
3. Journal of the American Academy of Dermatology. Guidelines of Care for the
Management Psoriasis and Psoriatic Arthritis: Section 1. Overview of psoriasis
and guidelines of care for the treatment of psoriasis with biologics. Available
at: https://www.jaad.org/article/S0190-9622(08)00273-9/fulltext (Last accessed:
June 2024)
About Sandoz
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar
medicines, with a growth strategy driven by its Purpose: pioneering access for
patients. More than 20,000 people of more than 100 nationalities work together
to ensure 800 million patient treatments are provided annually by Sandoz,
generating substantial global healthcare savings and an even larger social
impact. Its leading portfolio of approximately 1,500 products addresses diseases
from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz
traces its heritage back to 1886. Its history of breakthroughs includes Calcium
Sandoz in 1929, the world's first oral penicillin in 1951, and the first
biosimilar in 2006. In 2023, Sandoz recorded sales of USD 9.6 billion.
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 +49 171 838 4838                        +1 609 722 0982

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 Chris Lewis                             Laurent de Weck
 +49 174 244 9501                        +41 79 795 7364

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