医療従事者の為の最新医療ニュースや様々な情報・ツールを提供する医療総合サイト

Celltrion Finalizes Clinical Trials for Remsima SC, Planning to File a Marketing Authorization Application to the EMA in H2

2018年08月29日 AM11:59
このエントリーをはてなブックマークに追加


 

INCHEON, South Korea

Celltrion, Inc. (KRX:068270) today announced that the company has completed Phase 3 clinical trial for ‘Remsima SC’, the subcutaneous (SC) version of Remsima®, the autoimmune disease therapeutic antibody biosimilar of infliximab, with the preparation for filing a Marketing Authorization Application to the European Medicines Agency (EMA) now in the final stage, such as the analysis of clinical data.

Celltrion is set to complete the clinical analysis soon and to submit its application for Remsima SC to the EMA in the second half of this year.

In a bid to obtain its competitiveness in the TNF-α inhibitor (autoimmune disease therapeutic agent) market through ‘twin-track’ strategy together with the existing intravenous (IV) formulation of Remsima®, Celltrion has developed Remsima SC, the SC version of infliximab. Since May 2016, Celltrion has conducted Phase 1 and Phase 3 clinical trials on the safety, pharmacokinetic and efficacy assessment of Remsima SC.

The subcutaneous formulation allows patients to conveniently inject it by themselves according to the administration cycle unlike the intravenous formulation that require patients to visit hospitals for the administration thereof.

Celltrion expects that the potential demand base will include those patients who are satisfied with the therapeutic effects of infliximab and yet who want to be administered with the subcutaneous formulation, and those patients who are administered with the Abbvie’s Humira® and Amgen’s Enbrel®, which are global blockbuster biopharmaceuticals as TNF-α inhibitor SC formulation.

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA and EC’s approval for INFLECTRA® and Remsima®(CT-P13), respectively, which is the world’s first mAb biosimilar to receive approval from a regulatory agency in a developed country. For more information, visit www.celltrion.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20180828005894/en/

CONTACT

Celltrion, Inc.
Gunn Lee, +82-32-850-5168
Gunhyuk.lee@celltrion.com
or
Heewon
Park, +82-32-850-5356
Heewon.park@celltrion.com

Related Posts Plugin for WordPress, Blogger...
 

同じカテゴリーの記事 

  • Seattle Genetics Announces ADCETRIS® (Brentuximab Vedotin) Approval in Japan for Frontline Hodgkin Lymphoma
  • MicuRx Announces Receipt of FDA’s QIDP and Fast Track Designations for Contezolid and Contezolid Acefosamil
  • SanBio: Supplementary Information to the Notice Regarding an Equity and Business Alliance Between Five Companies for Joint Research on the Appropriate Use, Adoption, and Stable Distribution of Regenerative Cell Medicine SB623
  • 首例神经母细胞瘤患者成功接受采用自然杀伤T细胞(CAR-NKT)的创新型CAR疗法
  • AVITA Medical Announces FDA Approval of the RECELL® System for the Treatment of Severe Burns in the U.S.