Sandoz, a global leader in generic and biosimilar medicines, is pleased to announce the European Commission's (EC) approval of Pyzchiva® (biosimilar ustekinumab), developed and registered by Samsung Bioepis. Pyzchiva®'s approval marks a significant advancement in Sandoz's growth strategy and commitment to providing patients with access to high-quality, affordable therapies.

Pyzchiva® is now approved for use in gastroenterology, dermatology, and rheumatology, offering a safe and effective treatment option for patients suffering from chronic inflammatory diseases. This approval underscores Sandoz's dedication to pioneering access to life-changing medicines and improving patients' quality of life.

Rebecca Guntern, President of Sandoz Europe, expressed her enthusiasm, stating, "Chronic inflammatory diseases have a profound impact on patients' lives, and the approval of Pyzchiva® represents a critical step forward in addressing their unmet medical needs. We are committed to delivering innovative treatments that empower patients and healthcare providers across Europe."

The approval follows a robust development program, including thorough analytical, preclinical, and clinical studies, such as a Phase I PK/PD study and a Phase III confirmatory trial. These efforts confirmed Pyzchiva®'s equivalence to the reference medicine in terms of safety, efficacy, and quality.

Sandoz's collaboration with Samsung Bioepis, initiated in September 2023, has been instrumental in bringing Pyzchiva® to market. Under the agreement, Sandoz has the commercialization rights for Pyzchiva® in the US, Canada, the European Economic Area (EEA), Switzerland, and the UK, while Samsung Bioepis retains responsibilities for development, registration, intellectual property, manufacturing, and supply.

Pyzchiva® is a registered trademark of Samsung Bioepis Co. Ltd.