X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    $2 Million Gene Therapy Might Become The Standard In The US

    $2 Million Gene Therapy Might Become The Standard In The US

    Cancer Medicine Prices Jump 53% In Five Years In The U.S

    Food And Drug Administration User Fee Has Been Reauthorized

    Cancer Clinical Trials Get A Brand New Platform In Melbourne

    Report Indicates UK £62bn Behind In Global R&D Investment

    Wall Street Cautiously Optimistic After Gene Therapy Deals

    RoboCap: A Robotic Capsule to Improve Gut Drug Delivery

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development

    Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

    $2 Million Gene Therapy Might Become The Standard In The US

    $2 Million Gene Therapy Might Become The Standard In The US

    Cancer Medicine Prices Jump 53% In Five Years In The U.S

    Food And Drug Administration User Fee Has Been Reauthorized

    Cancer Clinical Trials Get A Brand New Platform In Melbourne

    Report Indicates UK £62bn Behind In Global R&D Investment

    Wall Street Cautiously Optimistic After Gene Therapy Deals

    RoboCap: A Robotic Capsule to Improve Gut Drug Delivery

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development

EMA Accepts Extension Marketing Authorisation Application for Review of Celltrions Remsima SC the subcutaneous version of Remsima

Content Team by Content Team
5th December 2018
in Drug Development, Manufacturing, Press Statements
EMA Accepts Extension Marketing Authorisation Application for Review of Celltrions Remsima SC the subcutaneous version of Remsima

Celltrion, Inc. announced that the EMA has accepted for review of the Extension Marketing Authorisation Application for ‘Remsima SC’, the subcutaneous (SC) version of Remsima®, the autoimmune disease therapeutic antibody biosimilar of infliximab. An opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on the Extension Marketing Authorisation Application for Remsima SC is expected in the second half of 2019.

In a bid to secure 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 for the safety, pharmacokinetic and efficacy assessment of Remsima SC.

The development of subcutaneous formulation of Remsima® is one of Celltrion’s marketing strategies to increase TNF-α inhibitor market share. The subcutaneous formulation allows patients to conveniently inject it by themselves according to the administration cycle, unlike intravenous formulation of Remsima that requires patients to visit hospitals for the administration thereof.

Celltrion expects that the potential users will include patients who are satisfied with the therapeutic effects of infliximab and yet want to be administered with the subcutaneous formulation.

“Celltrion is set to promote its Remsima® and Remsima SC as global blockbusters by increasing the Remsima brand share in TNF-α inhibitor market under the strategy of diversifying products with existing IV formulation of Remsima®, already sharing 52% of the Europe’s original medicine market.” says an official from Celltrion. “In addition to these efforts, we will lead the TNF- α inhibitor market with upcoming commercialization of the SC formulation of ‘CT-P17’ as a high-concentration formulation of a proposed adalimumab biosimilar referencing AbbVie’s Humira®, which is undergoing clinical trials.”

About Celltrion, Inc.
Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacturing 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®, 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.

 

Previous Post

QPS Expands U.S.-Based Phase I Clinical Trial Capabilities to Support the Growing Needs of Its Pharmaceutical, Biotechnology and CRO Partners

Next Post

Bluebird bio and Celgene Corporation Present Initial Data from Phase 1 Clinical Study of Next-Generation Anti-BCMA CAR T Cell Therapy

Related Posts

Clinical Trials

Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

8th November 2022
First Virtual Drug Study Tests 2 Likely Alzheimer Therapies
Clinical Trials

First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

7th November 2022
$2 Million Gene Therapy Might Become The Standard In The US
Drug Development

$2 Million Gene Therapy Might Become The Standard In The US

5th November 2022
News

Cancer Medicine Prices Jump 53% In Five Years In The U.S

3rd November 2022
FDA Approvals

Food And Drug Administration User Fee Has Been Reauthorized

3rd November 2022
Clinical Trials

Cancer Clinical Trials Get A Brand New Platform In Melbourne

3rd November 2022
Next Post
Bluebird bio and Celgene Corporation Present Initial Data from Phase 1 Clinical Study of Next-Generation Anti-BCMA CAR T Cell Therapy

Bluebird bio and Celgene Corporation Present Initial Data from Phase 1 Clinical Study of Next-Generation Anti-BCMA CAR T Cell Therapy

Latest News

Clinical Trials

Bispecific Cancer Drugs, Gene Therapy Advances At Next ASH

8th November 2022
Facilities & Operation

India Seeks Better Pharma Market Access In The UK: Official

8th November 2022
First Virtual Drug Study Tests 2 Likely Alzheimer Therapies
Clinical Trials

First Virtual Drug Study Tests 2 Likely Alzheimer Therapies

7th November 2022
Facilities & Operation

CPhI Pharma Index Shows Unprecedented Global Pharma Optimism

5th November 2022
$2 Million Gene Therapy Might Become The Standard In The US
Drug Development

$2 Million Gene Therapy Might Become The Standard In The US

5th November 2022
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In