Celltrion, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of autoinjector of SteQeyma??, a biosimilar to Stelara®? (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis (PsA) and Crohn's disease (CD). The positive CHMP opinion is for SteQeyma autoinjector in 45mg/0.5mL and 90mg/1mL, expanding the currently approved SteQeyma??
presentation, which includes 45 mg/0.5mL, 90mg/1mL in a pre-filled syringe and 45mg/0.5 mL in a pre-filled sy needle for subcutaneous injection, as well as 130mg/26mL concentrate for solution for intravenous infusion. With this new addition, SteQeyma?? broadens the administration option, giving patients and physicians access to a complete range of administration options.
The new SteQeyma?? autoinjector enables patients and caregivers to administer the medicine via a simple two-step process. The device includes two clear visual and audible indicators - a viewing window and audible clicks to support patients easily identify the injection status, which guide patients with successful administration.
SteQeyma?? Autoinjector is citrate-free with special thin-wall needle technology to help reduce injection pain. It also offers a 4-year shelf life and can be re-refrigerated, helping reduce product disposal.
SteQeyma?®? is currently licensed in more than 40 countries worldwide, including the US, Japan and EU countries.
