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FDA Approves Pyzchiva for Use in the United States

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Based on the presented evidence—including clinical studies showing that it has “equivalent efficacy and comparable safety” as its reference medicine—the FDA has approved Sandoz’s branded biosimilar, Pyzchiva (ustekinumab-ttwe) 45 mg/0.5 mL and 90 mg/mL pre-filled syringes for subcutaneous injection; 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion for subcutaneous injection; and 130 mg/26 mL (5 mg/mL) single-dose vial for intravenous infusion.1

Developed by Samsung Bioepis Co., Ltd, the drug is approved for all indications of its reference medicine; in the United States, Sandoz will be responsible for the commercialization process. The FDA also tentatively determined that Pyzchiva is interchangeable with the reference medicine, due to the fact that it is subject to an unexpired period of exclusivity for the first interchangeable biosimilar biological products.

The branded biosimilar is expected to hit the US marketplace by February 2025, potentially making it a part of the first wave of ustekinumab biosimilars to launch in the country, while also growing Sandoz’s immunology portfolio.

“This approval reflects our dedication to ensuring high-quality treatments are universally accessible,” said Claire D’Abreu-Hayling, Sandoz’s chief scientific officer. “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.”

As alluded to earlier, Pyzchiva is approved by the FDA for all indications of the reference medicine Stelara (ustekinumab), a human interleukin (IL)-12 and IL-23 antagonist developed by Johnson & Johnson,2 including for the treatment of adult patients with active psoriatic arthritis, moderately to severely active Crohn’s disease moderate, severe plaque psoriasis, and moderately to severely active ulcerative colitis. It can also be used by pediatric patients 6 years of age or older with moderate to severe plaque psoriasis and active psoriatic arthritis.3 Plaque psoriasis impacts approximately 80% to 90% of patients and is the most common type of psoriasis.4

“Systemic medications like biologics are a key treatment option for many people to manage symptoms of psoriasis and psoriatic arthritis,” noted Leah M. Howard, JD, president and CEO of the National Psoriasis Foundation. “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.”

The Sandoz-Samsung Bioepis development and commercialization agreement for ustekinumab with Samsung Bioepis dates back to September 2023. Per the deal, Sandoz can commercialize Pyzchiva in the United States, Canada, Switzerland, the United Kingdom, and the European Economic Area (EEA). On Samsung Bioepis’ end, it must uphold its end of the bargain, which consists of the development, registration, intellectual property, manufacturing and supply.

References

1. FDA approves biosimilar Pyzchiva (ustekinumab-ttwe), to be commercialized by Sandoz in US. Sanofi. July 1, 2024. Accessed July 3, 2024. https://www.sandoz.com/fda-approves-biosimilar-pyzchivar-ustekinumab-ttwe-be-commercialized-sandoz-us/

2. 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]

3. Pyzchiva. Prescribing Information. Available at: BLA 761373 and BLA 761425 PI MG and IFU.pdf (sandoz.com) [Last accessed: June 2024]

4. 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]

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