The European Commission (EC) has granted approval to Celltrion's ustekinumab biosimilar, SteQeyma (CT-P43), referencing Stelara, for the treatment of multiple chronic inflammatory diseases. This decision expands treatment options for patients across gastroenterology, dermatology, and rheumatology.
SteQeyma's approval encompasses conditions such as Crohn's disease, marking Celltrion's seventh biosimilar approved in the European Union. Stelara, the reference product, targets interleukin (IL)-12 and IL-23, key cytokines in immune and inflammatory responses.
The approval was supported by comprehensive clinical evidence, including a phase 3 study in moderate to severe plaque psoriasis patients. The study demonstrated SteQeyma's high similarity to Stelara in efficacy and safety, with no clinically meaningful differences observed.
Taehun Ha, senior vice president and head of Europe division at Celltrion, stated, "The EC approval of SteQeyma brings an important new therapeutic option to patients...This approval, alongside those of Remsima SC [Zymfentra in the US] and Yuflyma [adalimumab biosimilar], marks a key milestone in our strategy to strengthen Celltrion’s immunology offering."
Zymfentra and Adalimumab Biosimilar Expansion
Celltrion USA has announced an agreement with Cigna Healthcare and Express Scripts to expand patient access to Zymfentra (infliximab-dyyb), the only FDA-approved subcutaneous infliximab. Effective August 1, 2024, Zymfentra is listed as a preferred medication on Cigna’s medical formulary, covering 16.1 million insured lives.
Approved by the FDA in 2023, Zymfentra is indicated for maintenance therapy in adults with ulcerative colitis and Crohn’s disease after intravenous infliximab treatment. While considered a novel agent in the US, Zymfentra is viewed as a biosimilar or biobetter in international markets. The agreement aims to provide patients with increased flexibility and treatment choices.
MedImpact Healthcare Systems is also expanding access to biosimilars referencing Humira (adalimumab), including branded and unbranded versions of Simlandi (adalimumab-adaz), for patients with conditions like Crohn’s disease and rheumatoid arthritis. New patients can access these biosimilars through their pharmacy benefit, with existing Humira users able to continue their treatment. MedImpact emphasizes clinical interchangeability and affordability, offering biosimilars at the same cost as Humira.
Biosimilar Policy Briefing
The Association for Accessible Medicines (AAM) and its Biosimilars Council recently conducted a policy briefing for Congressional staff, addressing barriers to patient access to low-cost generic and biosimilar medicines. The discussion centered on patent-related issues, such as patent thickets, settlements, and “skinny labeling,” and their impact on drug prices.
David Gaugh, AAM’s interim president and CEO, highlighted that while generics and biosimilars significantly reduce drug costs, patent thickets often impede these savings. AAM also released its 2024 U.S. Generic & Biosimilar Medicines Savings Report, revealing that the use of generics and biosimilars saved the US health care system $445 billion in 2023.
