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

    AI Revolutionizing Drug Discovery and Clinical Development

    Drug-Development

    China’s Super Me-Too Drug Development: A New Pharma Frontier

    Omics Based Clinical Trials

    Asia Pacific Omics-Based Clinical Trials Market Growth

    AstraZeneca Eyes Acquisition To Develop Cell Therapies

    Advanced Instruments All Set To Merge With Nova Biomedical

    Taiho Pharmaceutical Buys Araris Biotech AG For $740 Million

    Oracle Wins the Asia Pacific Biopharma Excellence Awards

    Continuous Manufacturing is Improving Biopharma Production

    AI in Drug Commercialization Market to Grow CAGR 24% by 2032

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

    AI Revolutionizing Drug Discovery and Clinical Development

    Drug-Development

    China’s Super Me-Too Drug Development: A New Pharma Frontier

    Omics Based Clinical Trials

    Asia Pacific Omics-Based Clinical Trials Market Growth

    AstraZeneca Eyes Acquisition To Develop Cell Therapies

    Advanced Instruments All Set To Merge With Nova Biomedical

    Taiho Pharmaceutical Buys Araris Biotech AG For $740 Million

    Oracle Wins the Asia Pacific Biopharma Excellence Awards

    Continuous Manufacturing is Improving Biopharma Production

    AI in Drug Commercialization Market to Grow CAGR 24% by 2032

  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Europe

Biogen SB5 accepted for review by European Medicines Agency

Yuvraj_pawp by Yuvraj_pawp
17th July 2016
in Europe, News

The Marketing Authorization Application (MAA) for SB5, an adalimumab biosimilar candidate referencing Humira®1, has been accepted for review by the European Medicines Agency (EMA).

 

The MAA for SB5 is the third anti-TNF biosimilar candidate to be submitted to the EMA by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen .

 

Earlier this year, the European Commission approved BENEPALI® (etanercept), a biosimilar referencing Enbrel®2, and FLIXABI® (infliximab), a biosimilar referencing Remicade®3.

Humira is approved in the European Union (EU) for use in moderate to severe rheumatoid arthritis (RA), ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis, moderate to severely active Crohn’s disease, and moderate to severely active ulcerative colitis.

“The submission of SB5 by Samsung Bioepis reflects the joint goal of the partners to take the lead in expanding access to high-quality biologic therapies for those living with chronic inflammatory disorders,” said Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen. “At an estimated $4Bn a year,i Humira is among the EU’s largest single drug expenditures, but access still remains variable in many markets. If SB5 is approved, we will have the potential to make a substantial impact by bridging this access gap for patients while supporting the sustainability of healthcare systems.”

 

The MAA is based on a robust preclinical and clinical data package comparing SB5 with Humira. The clinical data include results from two head-to-head studies – a Phase I study in healthy volunteers that demonstrated pharmacokinetic bioequivalence to Humiraii and a Phase III, randomized, double-blind, multicenter study, in which SB5 demonstrated comparable efficacy, safety, and immunogenicity to Humira in patients with RA.iii The primary endpoint of the Phase III study, the ACR20 score response at Week 24, was met, demonstrating equivalent efficacy to Humira. Secondary endpoints demonstrated that SB5 has a comparable safety and immunogenicity profile to Humira.iii

About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com.  


1 Humira is a registered trademark of AbbVie.
2 Enbrel is a registered trademark of Wyeth LLC.
3 Remicade is a registered trademark of Janssen Biotech, Inc.

Reference
i Extrapolated from global sales from Global Data PMLive Top 50 Report.
iiShin D, Kim Y, Kim HS, et al. A Phase I Pharmacokinetic Study Comparing SB5, An Adalimumab Biosimilar, And Adalimumab Reference Product (Humira®) in Healthy Subjects. Ann Rheum Dis. 2015; 74 (suppl 2:1265).
iii Weinblatt ME, Baranauskaite A, Niebrzydowski J, et al. A Phase III, Randomized, Double-Blind Clinical Study Comparing SB5, an Adalimumab Biosimilar, with Adalimumab Reference Product (Humira®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-week results) [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10).

 

Contact:
BIOGEN
US MEDIA CONTACT:
Jason Glashow, + 1 781-464-3260
public.affairs@biogen.com


or
EU MEDIA CONTACT:
Shannon Altimari, +41 41 392 1677
publicaffairs.EU@biogen.com


or
INVESTOR CONTACT:
Mike Hencke, +1 781-464-2442
IR@biogen.com

 

Tags: Europe
Previous Post

Abbott laboratories says U.S. FDA approves tecnis symfony intraocular lenses

Next Post

Glaxosmithkline plc- ARIA Study Shows Superior Efficacy of Triumeq for Treatment-naïve women living with HIV

Related Posts

DHL Supply Chain
News

DHL Supply Chain comes up with New Pharma Hub in Singapore

19th April 2025
Healthcare Packaging
Asia

Amcor Healthcare Packaging Expansion in Asia Pacific

16th April 2025
Europe

Pharma Sector Seeks Seamless EU Medical Device Rules

24th March 2025
Drug Development

Advanced Instruments All Set To Merge With Nova Biomedical

22nd March 2025
Drug Development

Taiho Pharmaceutical Buys Araris Biotech AG For $740 Million

21st March 2025
Clinical Trials

Oracle Wins the Asia Pacific Biopharma Excellence Awards

21st March 2025
Next Post

Tagrisso met primary endpoint in phase III 2nd-line lung cancer trial

Qucik Links

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

Subscribe Us

System

  • Search
  • Sitemap
  • RSS Feed

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack
  • Newsletters Archive

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Articles
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • 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