NEW BRUNSWICK (dpa-AFX) - Sandoz Group AG (SDZNY), a Swiss maker of generic
and biosimilar medicines, announced Monday that the US Food and Drug
Administration has approved biosimilar Pyzchiva (ustekinumab-ttwe), developed by
Samsung Bioepis Co., Ltd, for all indications of its reference medicine Stelara
(ustekinumab) of Johnson & Johnson (JNJ).

Pyzchiva is indicated to treat patients 6 years or older with moderate to severe
plaque psoriasis who are candidates for phototherapy or systemic therapy, as
well as with active psoriatic arthritis. The medicine is also indicated for
adult patients with moderately to severely active Crohn's disease, and adult
patients with moderately to severely active ulcerative colitis.

The 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 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 said it 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.

Pyzchiva is expected to be among the first wave of ustekinumab biosimilars to
launch in the US.

Sandoz added that Pyzchiva is a key biosimilar value driver for the company over
the mid-term. The approval is a major step in advancing the Sandoz growth
strategy by extending the US immunology portfolio.

Sandoz entered into a development and commercialization agreement for biosimilar
ustekinumab with Samsung Bioepis in September 2023. Under the deal terms, Sandoz
has the right to commercialize Pyzchiva in the US, Canada, the European Economic
Area, Switzerland and the UK.

Samsung Bioepis remains responsible for development, registration, intellectual
property, manufacturing and supply.

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