Approval Based on Comprehensive Evidence Including Phase III Study Results
Celltrion is delighted to announce that the European Commission (EC) has granted approval for SteQeyma® (CT-P43), a biosimilar to Stelara® (ustekinumab). This new approval encompasses the treatment of several chronic inflammatory conditions within gastroenterology, dermatology, and rheumatology. SteQeyma® will now offer a significant therapeutic option across these diverse medical areas.
Stelara®, the reference product, has been a groundbreaking treatment for Crohn’s disease and other chronic inflammatory diseases by targeting interleukin (IL)-12 and IL-23 cytokines, which play a pivotal role in the inflammatory and immune response pathways. The decision from the European Commission follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2024, recognizing SteQeyma® as a valuable addition to the therapeutic landscape.
The EC’s approval of SteQeyma® is underpinned by a robust body of evidence, including results from a comprehensive Phase III clinical study conducted in adults with moderate to severe plaque psoriasis. This study primarily evaluated the Psoriasis Area and Severity Index (PASI), which measures the extent and severity of skin symptoms. The clinical data demonstrated that SteQeyma® is highly similar to its reference product, Stelara®, with no clinically significant differences in terms of efficacy and safety profiles.
Taehun Ha, Senior Vice President and Head of Europe Division at Celltrion, commented on the approval, stating, “The endorsement of SteQeyma® by the European Commission marks a crucial milestone in our commitment to delivering innovative and effective treatment options for patients with chronic inflammatory diseases. This biosimilar is a testament to our ongoing efforts to enhance patient access to high-quality, affordable biologic therapies. With recent approvals such as Remsima SC and Yuflyma, and the addition of Omlyclo in May, we are enthusiastic about further expanding our portfolio, particularly into the dermatology sector.”
SteQeyma® becomes Celltrion’s seventh biosimilar to receive approval in the European Union (EU). It joins a distinguished roster of biosimilars that includes Remsima® SC (a subcutaneous formulation of infliximab), Remsima® (biosimilar infliximab), Truxima® (biosimilar rituximab), Herzuma® (biosimilar trastuzumab), Yuflyma® (biosimilar adalimumab), Vegzelma® (biosimilar bevacizumab), and Omlyclo® (biosimilar omalizumab). This expansion reflects Celltrion’s robust and growing presence in the biosimilar market.
Celltrion remains steadfast in its dedication to advancing its biosimilar portfolio, focusing on expanding expertise in immunology to support patient access to effective and affordable biologic treatments. The approval of SteQeyma® further cements Celltrion’s role in addressing the needs of patients with chronic inflammatory diseases and exemplifies the company’s commitment to innovation and quality in the field of biologics.
The approval of SteQeyma® will likely improve patient access to effective treatments for chronic inflammatory diseases by offering a more affordable alternative to Stelara®. This move is expected to enhance treatment options for patients in Europe and contribute to cost savings in the healthcare system.
