Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • +44 (0)20 7454 5110
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All Public Company News
      • All Multimedia News
      • View All News Releases

      • Regulatory News

      • D/A/CH Regulatory News
      • UK Regulatory News
      • View All Regulatory News

  • Business & Money
      • Auto & Transportation

      • Aerospace & Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads & Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking & Road Transportation
      • View All Auto & Transportation

      • Business Technology

      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • View All Business Technology

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Financial Services & Investing

      • Accounting News & Issues
      • Acquisitions, Mergers & Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalisation
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • View All Financial Services & Investing

      • General Business

      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls & Research
      • Trade Show News
      • View All General Business

  • Science & Tech
      • Consumer Technology

      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • View All Consumer Technology

      • Energy & Natural Resources

      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil & Gas Discoveries
      • Utilities
      • Water Utilities
      • View All Energy & Natural Resources

      • Environ­ment

      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • Aerospace & Defence
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation & Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking & Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • Carriers & Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • Animals & Pets
      • Beers, Wines & Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics & Personal Care
      • Fashion
      • Food & Beverages
      • Furniture & Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewellery
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • Advertising
      • Art
      • Books
      • Entertainment
      • Film & Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • View All Entertain­ment & Media

      • Health

      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • View All Health

      • Sports

      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • View All Sports

      • Travel

      • Amusement Parks & Tourist Attractions
      • Gambling & Casinos
      • Hotels & Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • Animal Welfare
      • Corporate Social Responsibility
      • Economic News, Trends & Analysis
      • Education
      • Environmental
      • European Government
      • Labour & Union
      • Natural Disasters
      • Not For Profit
      • Public Safety
      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • View All People & Culture

  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • SocialBoost
  • Rooms
    • MediaRoom
    • ESG Rooms
  • AI Tools
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Hamburger menu
  • Cision PR Newswire UK provides press release distribution, targeting, monitoring, and marketing services
  • Send a Release
    • Phone

    • +44 (0)20 7454 5110 from 8 AM - 5:30 PM GMT

    • ALL CONTACT INFO
    • Contact Us

      +44 (0)20 7454 5110
      from 8 AM - 5:30 PM GMT

  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • News in Focus
    • Browse News Releases
    • Regulatory News
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
    • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • Overview
  • Distribution
  • Paid Placement
  • Multichannel Amplification
  • Disclosure Services
  • Cision Communications Cloud®
  • AI Tools
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists
  • General Enquiries
  • Media Enquiries
  • Partnerships
  • Client Login
  • Send a Release
  • Resources
  • Blog
  • Journalists

Samsung Bioepis' SB4 and SB2 Investigational Biosimilar Candidates Sustain Comparable Safety Profiles in One-Year Phase 3 Clinical Studies


News provided by

Samsung Bioepis

08 Nov, 2015, 07:49 GMT

Share this article

Share toX

Share this article

Share toX

- Positive one-year results show SB4 etanercept and SB2 infliximab investigational biosimilar candidates sustained comparable safety profiles observed in previously announced primary results

- 24-week results for SB5 adalimumab investigational biosimilar candidate demonstrate equivalent efficacy and comparable safety to Humira®

- SB4, SB2 and SB5 study results to be presented at 2015 ACR/ARHP Annual Meeting

INCHEON, Korea, Nov. 8, 2015 /PRNewswire/ -- Samsung Bioepis Co., Ltd. announced that SB4 etanercept and SB2 infliximab investigational biosimilar candidates sustained comparable safety profiles in 52- and 54-week clinical studies, respectively. Equally important, SB5 adalimumab investigational biosimilar candidate demonstrated both equivalent efficacy and comparable safety in a 24-week Phase 3 clinical study.

The latest Phase 3 results for SB4, SB2 and SB5 will be presented at the upcoming 2015 Annual Meeting of the American College of Rheumatology (ACR) and the Association for Rheumatology Health Professionals (ARHP) in San Francisco.

"The one-year clinical studies for SB4 and SB2 investigational biosimilar candidates provide encouraging indications of their comparable safety profiles," said Christopher Hansung Ko, CEO of Samsung Bioepis. "We will continue to focus on developing affordable biologic treatment options for patients who need these life-enhancing medications."

The 52-week SB4 study, which randomized 596 patients across 70 sites in 10 countries, showed ACR20 response rate of 80.8% in the SB4 arm versus 81.5% in the Enbrel® arm, fully supporting the 24-week study results of 78.1% and 80.3%, respectively.

The 54-week SB2 study, which randomized 584 patients across 73 sites in 11 countries, showed ACR20 response rate of 65.3% in the SB2 arm versus 69.2% in the Remicade® arm, fully supporting the 30-week study results of 64.1% and 66.0%, respectively.

The 24-week Phase 3 study of SB5, which randomized 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy, showed ACR20 response rate of 72.5% in the SB5 arm versus 72.0% in the Humira® arm. The safety profile of SB5 was comparable to Humira®.

The 2015 ACR/ARHP Annual Meeting will be held between November 6-11, 2015 at the Moscone Center in San Francisco. The following data presentations are part of the official ACR program. Abstracts are available online through the ACR website at www.acrannualmeeting.org:

SB4 Enbrel® (etanercept) data at ACR

Abstract # 2055 – Oral Presentation: A Phase III, Randomized, Double-Blind Clinical Study Comparing SB4, an Etanercept Biosimilar, with Etanercept Reference Product (Enbrel®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy: 52-week Results; Monday, Nov. 9, 2:30 – 4:00 p.m. PST; Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy III: Biosimilars; Location: West – First Floor

SB2 Remicade® (infliximab) data at ACR

Abstract # 2056 – Oral Presentation: A Randomized, Double-Blind, Phase III Study Comparing SB2, an Infliximab Biosimilar, to the Infliximab Reference Product (Remicade®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy: 54-Week Results; Monday, Nov. 9, 2:30 – 4:00 p.m. PST; Session Title: Rheumatoid Arthritis – Small Molecules, Biologics and Gene Therapy III: Biosimilars; Location: West – First Floor

SB5 Humira® (adalimumab) data at ACR

Abstract # 8L – Late-Breaking Poster Presentation: 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; Tuesday, Nov. 10, 9:00 – 11:00 a.m. PST; Session Title: ACR Late-Breaking Abstract Poster Presentations; Location: South – Halls B-C (Poster Hall)

Samsung Bioepis will also operate a booth at the 2015 ACR/ARHP Annual Meeting, and showcase its corporate story. The booth will be located in Room #1143 in Hall D of Moscone North.

About Samsung Bioepis Co., Ltd.

Samsung Bioepis was established in 2012 with a mission to develop affordable, high-quality biopharmaceutical products and to provide better patient access to life-enhancing medications. The company aims to be the world's leading biopharmaceutical company through innovations in product development and quality assurance.

Samsung Bioepis has commercial agreements with Biogen and Merck to commercialize and distribute biosimilar products in immunology, oncology and diabetes. The products and geographic responsibilities include:

Biogen

  • SB4, investigational biosimilar candidate referencing Enbrel® (etanercept) – European Union, Switzerland, Japan
  • SB2, investigational biosimilar candidate referencing Remicade® (infliximab) – European Union, Switzerland, Russia, Turkey
  • SB5, investigational biosimilar candidate referencing Humira® (adalimumab) – European Union, Switzerland, Russia, Turkey

Merck

  • SB4, investigational biosimilar candidate referencing Enbrel® (etanercept) – Worldwide, but excluding United States, European Union, Switzerland, Japan
  • SB2, investigational biosimilar candidate referencing Remicade® (infliximab) – Worldwide, including United States, but excluding European Union, Switzerland, Russia, Turkey
  • SB5, investigational biosimilar candidate referencing Humira® (adalimumab) – Worldwide, including United States, but excluding European Union, Switzerland, Russia, Turkey
  • SB3, investigational biosimilar candidate referencing Herceptin® (trastuzumab) –  Worldwide 
    MK-1293, investigational biosimilar candidate referencing Lantus® (insulin glargine) – Worldwide

Samsung Bioepis is a joint venture between Samsung Biologics and Biogen. For more information, please visit www.samsungbioepis.com.

MEDIA CONTACT:


Jamyung Cha

Samsung Bioepis Co., Ltd.

+82-32-455-6137

jamyung.cha@samsung.com

Mingi Hyun

Samsung Bioepis Co., Ltd.

+82-32-455-6128

mingi.hyun@samsung.com

Related Links

http://www.samsungbioepis.com

Modal title

Contact PR Newswire

  • +44 (0)20 7454 5110
    from 8 AM - 5:30 PM GMT
  • General Enquiries
  • Media Enquiries
  • Partnerships

Products

  • Content Distribution
  • Multimedia Services
  • Disclosure Services
  • Cision Communications Cloud®

About

  • About PR Newswire
  • About Cision
  • Partnering Opportunities
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United States
  • Vietnam

My Services

  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
  • Data Privacy

Do not sell or share my personal information:

  • Submit via Privacy@cision.com 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Customer Portal
  • Resources
  • Blog
  • Journalists
+44 (0)20 7454 5110
from 8 AM - 5:30 PM GMT
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookie Settings
Copyright © 2025 PR Newswire Europe Limited. All Rights Reserved. A Cision company.