Celltrion said on the 18th that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) recommended approval of a variation application to add an auto-injector (AI) formulation for the biosimilars of the autoimmune disease treatment "Stelara," "Steqeyma (STEQEYMA)" and "Qoyvolma (QOYVOLMA)."
According to the company, a CHMP recommendation is effectively considered the final approval. Accordingly, Celltrion will secure AI formulations of both Steqeyma and Qoyvolma in 45 mg and 90 mg doses. In particular, Qoyvolma also won additional approval for a 45 mg vial formulation through this variation, giving both products the same doses and formulations as the original medicine.
Qoyvolma expanded its indicated diseases to include ulcerative colitis (UC), in addition to plaque psoriasis, psoriatic arthritis, and Crohn's disease (CD) previously approved. Steqeyma and Qoyvolma are both biosimilars with the same ustekinumab ingredient as Stelara, but Steqeyma was developed with a strategy specialized for the U.S. market, and Qoyvolma for the European market.
Celltrion said the expanded formulations enable tailored prescription options suited to patient characteristics and administration settings. The AI formulation improves treatment access for patients who have difficulty visiting medical institutions because it is convenient for self-administration, and it can raise satisfaction among patients who prefer self-injection.
With demand for self-injection formulations rising mainly in major European countries, prescriptions are expected to expand as Steqeyma and Qoyvolma now offer an AI formulation in addition to the existing prefilled syringe (PFS).
Celltrion plans to expand its market share in the global ustekinumab market, including Europe. According to IQVIA, the global market for ustekinumab last year was estimated at about $21.6606 billion (30.3248 trillion won).
A Celltrion official said, "Steqeyma and Qoyvolma have been growing quickly, winning bids one after another since their launch in Europe," and added, "with the addition of the AI formulation, we now have a full lineup equivalent to the original, which will further accelerate market expansion."