BRIEF—Celltrion wins positive EU opinion for SteQeyma autoinjector

South Korean biosimilars specialist Celltrion said the European medicines regulator has adopted a positive opinion for an autoinjector version of SteQeyma, its biosimilar to Stelara (ustekinumab).

The opinion covers use of the SteQeyma autoinjector in plaque psoriasis, psoriatic arthritis and Crohn’s disease, with doses of 45mg and 90mg, expanding the product’s range of approved presentations in Europe.

Celltrion said the new device is designed to simplify self-administration, using a two-step injection process with visual and audible indicators to confirm successful dosing. The autoinjector is citrate-free and uses thin-wall needle technology intended to reduce injection discomfort.

The company added that the device has a four-year shelf life and can be re-refrigerated, features that may help limit waste and support more flexible use in routine care.

SteQeyma is already licensed in more than 40 countries, including the USA, Japan and across the EU, and further strengthens Celltrion’s growing immunology portfolio as competition in the ustekinumab biosimilar market continues to intensify.