Accelerating Global Market Expansion by Broadening Treatment Options
Celltrion announced on December 18 that it has received a "positive opinion for approval" from the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) regarding its application to add autoinjector formulations for the Stelara biosimilars "STEQEYMA" and "QOYVOLMA."
As the CHMP's positive opinion on the variation application is considered equivalent to approval, Celltrion has secured 45mg and 90mg autoinjector formulations for both STEQEYMA and QOYVOLMA. With this variation approval, QOYVOLMA has also obtained approval for the 45mg vial formulation, enabling both products to offer a "full lineup" that matches all doses and formulations of the originator, thereby further strengthening their competitiveness.
Celltrion plans to strategically address the diverse needs of healthcare settings by expanding treatment options for both products, enabling tailored prescriptions according to administration environment and patient characteristics. In particular, the autoinjector formulation offers greater convenience for self-injection, improving treatment accessibility for patients who have difficulty visiting medical institutions and increasing satisfaction among those who prefer self-administration.
Recently, demand for self-injection formulations has been increasing, especially in major European countries. As a result, preference for prescribing STEQEYMA and QOYVOLMA, which now offer both pre-filled syringe (PFS) and autoinjector formulations, is expected to rise significantly.
Both STEQEYMA and QOYVOLMA are biosimilars of the autoimmune disease treatment Stelara (active ingredient ustekinumab). To flexibly respond to the complex patent landscape in various European countries, Celltrion obtained separate approvals for the two products with different indications. QOYVOLMA, in addition to the indications held by STEQEYMA-plaque psoriasis, psoriatic arthritis, and Crohn's disease (CD)-has also been approved for ulcerative colitis (UC).
Building on the enhanced competitiveness of STEQEYMA and QOYVOLMA, Celltrion aims to expand its market share in the global ustekinumab market, including Europe. According to pharmaceutical market research firm IQVIA, the global ustekinumab market is estimated to be worth approximately $21.66 billion (about 30.3248 trillion KRW) as of 2024.
A Celltrion representative stated, "STEQEYMA and QOYVOLMA have shown rapid growth, winning consecutive tenders immediately after their launch in Europe. With the addition of the autoinjector formulation, we now have a full lineup equivalent to the originator, offering a wider range of treatment options and accelerating market expansion. Celltrion will continue to develop formulations that enhance patient convenience and further strengthen our competitiveness in the global market."
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