Celltrion has announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab).

Celltrion 宣布，美国食品药品监督管理局 (FDA) 已批准 STEQEYMA®（乌司奴单抗-stba）的新版本，该药是 STELARA®（乌司奴单抗）的生物类似药。

STEQEYMA, previously known as CT-P43, is a human interleukin (IL)-12 and IL-23 antagonist. It is indicated for the treatment of several immune-mediated diseases, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. It is available in subcutaneous and intravenous forms.

STEQEYMA，曾用名CT-P43，是一种人白细胞介素（IL）-12和IL-23拮抗剂。它适用于治疗多种免疫介导的疾病，包括斑块型银屑病、银屑病关节炎、克罗恩病和溃疡性结肠炎。该药物有皮下注射和静脉注射两种形式可供使用。

The subcutaneous formulations include 45mg/0.5mL and 90mg/1mL in prefilled syringes, as well as a 45mg/0.5mL vial. The intravenous version is offered as a 130mg/26mL solution in a single-dose vial..

皮下注射制剂包括45毫克/0.5毫升和90毫克/1毫升的预充式注射器，以及45毫克/0.5毫升的瓶装制剂。静脉注射版本为130毫克/26毫升溶液，采用单剂量瓶装。

The approval covers a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. This new format is indicated for children aged 6 to 17 years, weighing under 60kg, who are being treated for plaque psoriasis (PsO) or psoriatic arthritis (PsA).

批准涵盖了一种45mg/0.5mL的单剂量小瓶溶液，用于皮下注射。这一新剂型适用于6至17岁、体重低于60公斤、正在接受斑块型银屑病（PsO）或银屑病关节炎（PsA）治疗的儿童。

This latest approval means that STEQEYMA now mirrors all dosage forms and strengths of its reference medicine, providing healthcare professionals with increased flexibility in managing treatment for both adult and paediatric patients.

这一最新的批准意味着STEYEYMA现在与其参比药物的所有剂型和剂量强度保持一致，为医疗保健专业人员在管理成人和儿童患者的治疗方面提供了更大的灵活性。

Previously, in December 2024, the FDA approved STEQEYMA in multiple formats, including 45mg/0.5mL and 90mg/mL solutions in prefilled syringes for subcutaneous use, and 130mg/26mL for intravenous infusion. These were approved for use in adults and children aged 6 years and above with PsO and PsA, and for adults with Crohn’s disease and ulcerative colitis..

此前，FDA 于 2024 年 12 月批准了 STEQEYMA 的多种剂型，包括用于皮下注射的 45mg/0.5mL 和 90mg/mL 预充式注射器，以及用于静脉输注的 130mg/26mL。这些剂型获批用于 6 岁及以上患有 PsO 和 PsA 的成人和儿童，以及患有克罗恩病和溃疡性结肠炎的成人。

The newly approved presentation is designed to support more tailored treatment approaches in children and aligns with the full range of indications of the original reference product.

新批准的剂型旨在支持针对儿童更加定制化的治疗方案，并与原参照药品的全部适应症保持一致。

The FDA’s approval was based on comprehensive data, including findings from a phase III clinical study involving adults with moderate to severe plaque psoriasis.

FDA的批准是基于综合数据，包括一项涉及中度至重度斑块型银屑病成人的III期临床研究结果。

The results confirmed that STEQEYMA closely matches the reference product in terms of safety, efficacy, and overall clinical performance.

结果证实，STEYEYMA在安全性、有效性和整体临床表现方面与参比制剂非常接近。