Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules
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. 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. 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.” 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. 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 for PYZCHIVA. 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.
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) [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] SandozSandoz (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 SandozSandoz, 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, SandozSandoz recorded sales of USD 9.6 billion. Global Media Relations contacts Investor Relations contacts Global.MediaRelations@sandoz.com Investor.Relations@sandoz.com Joerg E. Allgaeuer
+49 171 838 4838 Karen M. King
+1 609 722 0982 Chris Lewis
+49 174 244 9501 Laurent de Weck
Global Media Release Pyzchiva FDA Approval