EC Approves Celltrion's Stelara Biosimilar SteQeyma for Inflammatory Diseases

The European Commission (EC) has given its approval to Celltrion’s SteQeyma (CT-P43), an ustekinumab biosimilar that references Johnson & Johnson’s Stelara, for the treatment of multiple chronic inflammatory diseases. This interleukin (IL)-12 and IL-23 antagonist has been authorized for use in gastroenterology, dermatology, and rheumatology and will be available in both subcutaneous and intravenous forms.

According to the European Medicines Agency (EMA), a biosimilar is a biological medicine that is highly similar to one already approved in the EU. This means patients can expect the same level of safety and effectiveness from the biosimilar as they would from the original product, potentially benefiting from lower healthcare costs.

The EC’s approval of SteQeyma follows a recent recommendation from the EMA’s human medicines committee. This decision is backed by a wealth of evidence, including positive outcomes from a phase 3 trial in adults suffering from moderate-to-severe plaque psoriasis.

Taehun Ha, Celltrion’s senior vice president and head of the European division, expressed enthusiasm about the approval. Ha stated: “The EC approval of SteQeyma introduces an important new therapeutic option for patients. We’re excited to launch this innovative therapy, which has a proven track record in treating Crohn’s disease and other immune disorders.” He also emphasized that this approval is a significant milestone in Celltrion’s strategy to bolster its immunology portfolio and expand into the dermatology sector.

SteQeyma marks the seventh biosimilar that Celltrion has had approved for use in the EU. Earlier in May, the EC also approved Celltrion’s Omlyclo (CT-P39), an omalizumab biosimilar that references Novartis and Genentech’s Xolair. Omlyclo is indicated for use in patients with allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps.

The EC’s decision on Omlyclo was particularly noteworthy as it made Omlyclo the first omalizumab biosimilar to be approved in Europe. This approval was based on clinical evidence, including results from a global phase 3 trial comparing Omlyclo against Xolair in patients with CSU for up to 40 weeks.

In addition, Celltrion recently reported promising results from a late-stage study of another biosimilar candidate, CT-P47, which references Roche’s RoActemra (tocilizumab). This investigational drug was evaluated in patients with moderate-to-severe rheumatoid arthritis. The comparative study showed that CT-P47 was highly similar in terms of efficacy and safety to the reference product up to week 32.

Overall, these approvals and ongoing studies highlight Celltrion’s commitment to expanding its range of biosimilars, thereby providing more treatment options for patients with various chronic inflammatory conditions. This approach not only aims to enhance patient care but also offers a potential reduction in healthcare costs, making advanced treatments more accessible.

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