Samsung Bioepis launched PYZCHIVA (ustekinumab-ttwe), a biosimilar to Stelara, in the United States. The drug is approved to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis and will be available in various formulations through their partner, Sandoz. This launch follows a 2023 commercialization agreement with Sandoz, with Samsung Bioepis retaining responsibility for development, manufacturing, and supply.
This launch is important because it introduces a new, potentially more affordable treatment option for patients with inflammatory conditions. Increased competition in the market can drive down costs, benefiting both patients and the healthcare system as a whole. This availability can enhance access to vital therapies for individuals who might otherwise face financial barriers to treatment.
PYZCHIVA’s availability begins prior to the February 2025 start date of the license agreement between Samsung Bioepis and Janssen Biotech Inc. Samsung Bioepis currently has ten approved biosimilars in the US market, with five commercially available, highlighting their significant presence in this rapidly expanding sector of the pharmaceutical industry. This adds to their portfolio which encompasses a range of therapeutic areas.
This launch positions Samsung Bioepis to further solidify its role in the biosimilars market. With a focus on expanding patient access to treatment, the company aims to strengthen its product portfolio and contribute to creating a more cost-effective healthcare landscape. The impact on the overall market for these specific therapies will depend on real-world effectiveness data and market adoption rates of PYZCHIVA.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
