Samsung Bioepis Gains European Commission Approval For PYZCHIVA, a Biosimilar to Stelara (Ustekinumab)
INCHEON, Korea – April 22 2024 – Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for PYZCHIVA™, a biosimilar to Stelara1,2 (ustekinumab), paving the way for expanding its immunology portfolio. PYZCHIVA is approved for the treatment of certain autoimmune disorders in gastroenterology, dermatology and rheumatology.
“We are proud to have our fourth immunology biosimilar approved in Europe,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader, at Samsung Bioepis. “With the latest approval, we are pleased to make an important progress towards providing additional treatment options for patients suffering chronic, autoimmune diseases in Europe.”
Ustekinumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that prevents abnormal regulation of IL-12 and IL-23 associated with immune-mediated diseases.
The EC approval for PYZCHIVA was based on a totality of evidence including analytical, non-clinical and clinical data demonstrating it is highly similar to the reference medicine Stelara, in terms of structure, biological activity and efficacy, comparable safety and immunogenicity profile3 : The randomized, double-blind, three-arm, parallel-group, single-dose Phase 1 clinical study (NCT04772274) demonstrated pharmacokinetics (PK) equivalence and comparable safety, tolerability, immunogenicity profiles between PYZCHIVA and Stelara in health volunteers. In addition, the randomized, double-blind, multicenter Phase 3 clinical study (NCT04967508), conducted in patients with moderate to severe plaque psoriasis, demonstrated biosimilarity of PYZCHIVA with Stelara through equivalent efficacy and comparable safety and PK profiles up to Week 28.
PYZCHIVA will be commercialized by Sandoz under Samsung Bioepis and Sandoz’s partnership. Two companies entered into a development and commercialization agreement for PYZCHIVA in September 2023 for the United States, Canada, European Economic Area (EEA), Switzerland and United Kingdom (UK).
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X (Twitter), LinkedIn.
1 Stelara is a trademark of Johnson & Johnson.
2 European Medicines Agency. Stelara Product Information. Available at https://www.ema.europa.eu/en/documents/product-information/stelara-epar-product-information_en.pdf Accessed in April 2024
3 European Medicines Agency, Biosimilar Medicines: Overview. Available at: https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview
Source:- Samsung Bioepis
