Celltrion receives positive CHMP opinion for SteQeyma autoinjector
Friday, December 19, 2025
Celltrion has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the autoinjector version of SteQeyma, a biosimilar to Stelara (ustekinumab). The product is indicated for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease.
The positive CHMP opinion covers the SteQeyma autoinjector in 45 mg/0.5 mL and 90 mg/1 mL strengths. This expands the existing SteQeyma range, which already includes pre-filled syringes, a vial for subcutaneous injection, and a concentrate for intravenous infusion.
The addition of the autoinjector broadens administration options for patients and healthcare professionals. The device is designed for ease of use, allowing administration through a simple two-step process. It includes visual and audible indicators to help confirm injection status and support correct use. The autoinjector is citrate-free and uses thin-wall needle technology to help reduce injection pain. It also offers a shelf life of up to four years and can be re-refrigerated, which may help reduce product waste.
SteQeyma is currently approved in more than 40 countries worldwide, including the US, Japan and countries in Europe. The product adds to Celltrion’s growing immunology portfolio, which includes several biosimilars across inflammatory and oncology indications.
Source: businesswire.com
