The European Commission (EC) has approved Celltrion’s SteQeyma (CT-P43), an ustekinumab biosimilar referencing Johnson & Johnson’s Stelara, to treat multiple chronic inflammatory diseases.
The interleukin (IL)-12 and IL-23 antagonist has been authorised for use in gastroenterology, dermatology and rheumatology indications, and will be available in subcutaneous and intravenous formulations.
A biosimilar, according to the European Medicines Agency (EMA), is a biological medicine that is highly similar to one already approved in the EU. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may benefit from lower healthcare costs.
The EC’s decision on SteQeyma follows a recent recommendation from the EMA’s human medicines committee and is supported by a totality of evidence, including positive results from a phase 3 trial in adults with moderate-to-severe plaque psoriasis.
Taehun Ha, senior vice president and head of Europe division at Celltrion, said: “The EC approval of SteQeyma brings an important new therapeutic option to patients and we’re excited to launch this innovative therapy, with a proven track record in Crohn’s and other immune diseases.”
Ha added that the approval “marks a key milestone” in Celltrion’s strategy to strengthen its immunology offering, and that the company is “looking forward to expanding [its] portfolio into the dermatology sector”.
SteQeyma is Celltrion’s seventh biosimilar authorised for use in the EU, following the approval of Omlyclo (CT-P39) in May.
The omalizumab biosimilar referencing Novartis and Genentech’s Xolair was indicated for use in patients with allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps.
The EC’s decision made Omlyclo the first omalizumab biosimilar to be approved in Europe and was based on clinical evidence including results from a global phase 3 trial, which compared Omlyclo against Xolair in patients with the skin condition CSU for up to 40 weeks.
Celltrion also recently
shared
promising results from a late-stage study of its biosimilar candidate referencing Roche’s RoActemra (tocilizumab) in patients with moderate-to-severe rheumatoid arthritis.
The comparative study demonstrated that the investigational drug, CT-P47, was highly similar in terms of efficacy and safety to the reference product up to week 32.
