Basel, February 24, 2025 <\/strong>Sandoz (SIX:SDZ\/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, announces the launch of Pyzchiva\u00ae* (ustekinumab-ttwe) in the US. From today, the medicine is commercially available to patients across the US.<\/p>\n Developed by Samsung Bioepis Co., Ltd., and commercialized by Sandoz, Pyzchiva\u00ae has been approved by the US Food and Drug Administration (FDA) for the treatment of certain chronic inflammatory diseases, with the same indications as reference medicine Stelara\u00ae**<\/sup>[5].<\/p>\n Pyzchiva\u00ae is a key biosimilar value driver for Sandoz, contributing to the companys overall growth strategy. The company ranks number one in biosimilars globally and across key markets in Europe. The commercial availability of Pyzchiva\u00ae, which builds on the US launch of Hyrimoz\u00ae in July 2023, marks an important step in the Sandoz strategic ambition to become number one in biosimilars in the US.<\/p>\n Keren Haruvi,\u00a0President,\u00a0Sandoz North America, said:\u00a0This is an important moment for millions of patients living with chronic autoimmune diseases.[1-4] The launch of Pyzchiva\u00ae reinforces our commitment to broaden access to treatment options for patients, while helping to build a more sustainable healthcare system in the US so that everyone can access the medicines they need, when they need them.<\/p>\n Pyzchiva\u00ae offers an affordable option for patients who could benefit from treatment with ustekinumab. It also provides the full suite of dosing options to meet the needs of a variety of patients and is expected to offer interchangeability in the first half of 2025. Pyzchiva\u00ae elevates the patient experience with extended stability, including the ability to be re-refrigerated, unlike the reference medicine.<\/p>\n Leah M. Howard, J.D., the president and CEO of the National Psoriasis Foundation, said: Psoriasis and psoriatic arthritis are chronic diseases that can be treated with biologics, but those medications are often not as accessible or affordable as they should be for those who could benefit most from them. Biosimilars offer great potential for putting these effective treatment options within reach of those who may have been previously unable to afford them.<\/p>\n Sandoz is providing comprehensive support resources for patients who are prescribed Pyzchiva\u00ae, including information about insurance coverage\/benefit investigation, self-injection training, and a co-pay program for commercially insured patients.<\/p>\n This launch is in accordance with the settlement and license agreement with Johnson & Johnson for the US market, previously announced by Samsung Bioepis Co., Ltd. Sandoz entered into a commercialization agreement for biosimilar ustekinumab with Samsung Bioepis in September 2023. Under the terms of the agreement, Sandoz has the right to commercialize Pyzchiva\u00ae in the US, Canada, the European Economic Area, Switzerland, the UK and Brazil. Samsung Bioepis Co., Ltd. remains responsible for development, registration, intellectual property, manufacturing and supply.<\/p>\n *Pyzchiva\u00ae is a trademark of Samsung Bioepis Co. Ltd. \u00a0<\/strong><\/p>\n About Pyzchiva\u00ae (ustekinumab-ttwe)<\/strong><\/p>\n Ustekinumab, the active ingredient in Pyzchiva\u00ae, is a human monoclonal antibody targeting IL-12 and IL-23, which are cytokines that when overproduced can cause inflammation. This inflammation plays a role in the development of certain autoimmune conditions. Pyzchiva\u00ae works by blocking IL-12 and IL-23 proteins.[6]<\/p>\n Pyzchiva\u00ae has been approved by the FDA to treat adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohns disease and moderately to severely active ulcerative colitis, as well as pediatric patients with moderate to severe plaque psoriasis and active psoriatic arthritis.<\/p>\n Pyzchiva\u00ae is available in 45 mg\/0.5 mL and 90 mg\/mL pre-filled syringes, 130 mg\/26 mL single-dose vials for intravenous injection, and 45 mg\/0.5 mL subcutaneous single-dose vials.[6]<\/p>\n INDICATIONS<\/strong> SELECT IMPORTANT SAFETY INFORMATION<\/u><\/strong><\/p>\n CONTRAINDICATIONS<\/strong>:\u00a0Clinically significant hypersensitivity to ustekinumab or to any of the excipients.<\/p>\n WARNINGS AND PRECAUTIONS<\/strong>:\u00a0Infections<\/em><\/strong>:<\/em>\u00a0Serious 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.\u00a0Theoretical Risk for Particular Infections<\/em><\/strong>:<\/em>\u00a0Serious 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.\u00a0Tuberculosis (TB)<\/em><\/strong>:<\/em>\u00a0Evaluate patients for TB prior to initiating treatment with PYZCHIVA. Initiate treatment of latent TB before administering PYZCHIVA.\u00a0Malignancies<\/em><\/strong>:<\/em>\u00a0Ustekinumab 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.\u00a0Hypersensitivity<\/em><\/strong> Reactions:<\/em>\u00a0If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue PYZCHIVA.\u00a0Posterior Reversible Encephalopathy Syndrome (PRES)<\/em><\/strong>:<\/em>\u00a0If PRES is suspected, treat promptly and discontinue PYZCHIVA.<\/p>\n Immunizations<\/u><\/em><\/strong>:<\/em>\u00a0Avoid use of live vaccines in patients during treatment with PYZCHIVA.\u00a0Noninfectious Pneumonia<\/em><\/strong>:<\/em>\u00a0Cases 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.<\/p>\n ADVERSE REACTIONS<\/strong>:\u00a0Most common adverse reactions are\u00a0Psoriasis (3%):<\/em>\u00a0nasopharyngitis, upper respiratory tract infection, headache, and fatigue.\u00a0Crohns Disease, induction (3%):<\/em>\u00a0vomiting.\u00a0Crohns Disease, maintenance (3%):<\/em>\u00a0nasopharyngitis, injection site erythema, vulvovaginal candidiasis\/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis.\u00a0Ulcerative colitis, induction (3%):<\/em>\u00a0nasopharyngitis.\u00a0Ulcerative colitis, maintenance (3%):<\/em>\u00a0nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea.<\/p>\n This is not the complete list of all the safety information for PYZCHIVA. Please see full\u00a0<\/strong>Prescribing Information<\/strong><\/a>\u00a0for PYZCHIVA.<\/strong><\/p>\n About Hyrimoz\u00ae (adalimumab-adaz)<\/strong> INDICATIONS\u00a0\u00a0<\/strong><\/p>\n HYRIMOZ\u00ae (adalimumab-adaz)<\/strong> is a tumor necrosis factor (TNF)-blocker indicated for Rheumatoid Arthritis (RA)<\/strong>: reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. HYRIMOZ can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Juvenile Idiopathic Arthritis (JIA)<\/strong>: reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older. HYRIMOZ can be used alone or in combination with methotrexate. Psoriatic Arthritis (PsA)<\/strong>: reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. HYRIMOZ can be used alone or in combination with non-biologic DMARDs. Ankylosing Spondylitis (AS)<\/strong>: reducing signs and symptoms in adult patients with active AS. Crohns Disease (CD)<\/strong>: treatment of moderately to severely active CD in adults and pediatric patients 6 years of age and older. Ulcerative Colitis (UC)<\/strong>: treatment of moderately to severely active UC in adult patients. Limitations of Use:<\/u> Effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF-blockers. Plaque Psoriasis (Ps)<\/strong>: treatment of adult patients with moderate to severe chronic Ps who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HYRIMOZ should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa (HS)<\/strong>: treatment of moderate to severe HS in adult patients.\u00a0Uveitis<\/strong>: Treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.<\/p>\n SELECT IMPORTANT SAFETY INFORMATION<\/strong><\/p>\n
**Stelara\u00ae is a registered trademark of Johnson & Johnson (USA).<\/p>\n
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 Crohns disease, adult patients with moderately to severely active ulcerative colitis.<\/p>\n
Adalimumab, the active ingredient in Hyrimoz\u00ae, is an inhibitor of tumor necrosis factor (TNF), a protein that is overproduced in certain autoimmune conditions including rheumatoid arthritis, plaque psoriasis, Crohn’s disease and ulcerative colitis causing inflammation and tissue destruction in joints, mucosa or skin. In some cases of autoimmune disease, the immune system damages the bodys own tissues. Hyrimoz\u00ae targets and blocks the protein that contributes to disease symptoms.[7]<\/p>\n
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