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

PR62471

INCHEON, Korea, Nov. 8, 2015 /PRNewswire=KYODO JBN/ --

-- 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(R)

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

Meeting

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(R) 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(R) 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(R) arm. The

safety profile of SB5 was comparable to Humira(R).

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 http://www.acrannualmeeting.org :

SB4 Enbrel(R) (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(R)) 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(R) (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(R)) 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(R) (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(R)) 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(R)

      (etanercept) - European Union, Switzerland, Japan

    - SB2, investigational biosimilar candidate referencing Remicade(R)

      (infliximab) -European Union, Switzerland, Russia, Turkey

    - SB5, investigational biosimilar candidate referencing Humira(R)

      (adalimumab) - European Union, Switzerland, Russia, Turkey

Merck

    - SB4, investigational biosimilar candidate referencing Enbrel(R)

      (etanercept)- Worldwide, but excluding United States, European Union,

      Switzerland, Japan

    - SB2, investigational biosimilar candidate referencing Remicade(R)

      (infliximab) -Worldwide, including United States, but excluding

       European Union, Switzerland, Russia, Turkey

    - SB5, investigational biosimilar candidate referencing Humira(R)

      (adalimumab) - Worldwide, including United States, but excluding

      European Union, Switzerland, Russia, Turkey

    - SB3, investigational biosimilar candidate referencing Herceptin(R)

      (trastuzumab) - Worldwide MK-1293, investigational biosimilar candidate

      referencing Lantus(R) (insulin glargine) - Worldwide

Samsung Bioepis is a joint venture between Samsung Biologics and Biogen. For

more information, please visit http://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

SOURCE: Samsung Bioepis