Samsung Bioepis to Present Eight New Abstracts on Three Anti-TNF-α Biosimilar Molecules at the Annual European Congress on Rheumatology (EULAR 2016)

INCHEON, Korea

Samsung Bioepis Co., Ltd. today announced it will present eight abstracts on its anti-TNF-α portfolio, including switching data for Benepali^® (etanercept), Flixabi^® (infliximab) and SB5 (adalimumab) investigational biosimilar candidate, at the upcoming Annual European Congress on Rheumatology (EULAR 2016) between June 8-11, 2016 in London, United Kingdom. Samsung Bioepis will also operate a booth and host a satellite symposium.

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Christopher Hansung Ko, President & CEO of Samsung Bioepis (Photo: Business Wire)

“Anti-TNF-α biosimilars continue to play an increasingly important role in treating autoimmune diseases across Europe,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “We look forward to presenting our new data on our anti-TNF-α portfolio.”

The eight accepted abstracts are as follows:

Benepali^® (etanercept), also known as SB4

• LONG-TERM SAFETY AND EFFICACY OF SB4 (ETANERCEPT BIOSIMILAR) IN PATIENTS WITH RHEUMATOID ARTHRITIS: COMPARISON BETWEEN CONTINUING SB4 AND SWITCHING FROM ETANERCEPT REFERENCE PRODUCT TO SB4 [POSTER SESSION: THU0150, June 9, 2016 at 11:45]

Flixabi^® (infliximab), also known as SB2

• COMPARABLE SAFETY AND IMMUNOGENICITY AND SUSTAINED EFFICACY AFTER TRANSITION TO SB2 (AN INFLIXIMAB BIOSIMILAR) VS ONGOING INFLIXIMAB REFERENCE PRODUCT IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS OF PHASE III TRANSITION STUDY [POSTER TOUR: FRI0162, June 10, 2016 at 11:50]
• EFFICACY AND SAFETY ANALYSIS BY OVERALL ANTI-DRUG ANTIBODY RESULTS UP TO WEEK 30 IN PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH SB2 (AN INFLIXIMAB BIOSIMILAR) OR INFLIXIMAB REFERENCE PRODUCT IN PHASE III STUDY [POSTER SESSION: THU0140, June 9, 2016 at 11:45]
• THE 54-WEEK RESULTS OF INTERFERON-Γ RELEASE ASSAY IN A PHASE III STUDY COMPARING SB2, AN INFLIXIMAB BIOSIMILAR, TO INFLIXIMAB REFERENCE PRODUCT IN PATIENTS WITH RHEUMATOID ARTHRITIS [POSTER SESSION: THU0149, June 9, 2016 at 11:45]

SB5 (adalimumab) investigational biosimilar candidate

• SUSTAINED EFFICACY AND COMPARABLE SAFETY AND IMMUNOGENICITY AFTER TRANSITION TO SB5 (AN ADALIMUMAB BIOSIMILAR) VS CONTINUATION OF THE ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULT OF PHASE III STUDY [POSTER TOUR: FRI0161, June 10, 2016 at 11:50]
• SECONDARY EFFICACY RESULTS UP TO WEEK 24 FROM A PHASE III STUDY COMPARING SB5 (AN ADALIMUMAB BIOSIMILAR) WITH ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS DESPITE METHOTREXATE THERAPY [POSTER SESSION: THU0138, June 9, 2016 at 11:45]
• IMPACT OF ANTI-DRUG ANTIBODIES ON EFFICACY AND SAFETY UP TO WEEK 24 FROM A PHASE III STUDY COMPARING SB5 (AN ADALIMUMAB BIOSIMILAR) WITH ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS DESPITE METHOTREXATE THERAPY [POSTER SESSION: THU0146, June 9, 2016 at 11:45]
• A PHASE I PHARMACOKINETIC STUDY COMPARING PRE-FILLED PEN AND PRE-FILLED SYRINGE OF SB5, AN ADALIMUMAB BIOSIMILAR IN HEALTHY SUBJECTS [ABSTRACT PUBLICATION]

Samsung Bioepis will operate a booth at the Annual European Congress on Rheumatology (EULAR 2016), where visitors can learn about the company. The booth will be located in Stand 200, Hall S16, South Event Halls (Level 1) of ExCeL London.

Samsung Bioepis will also host a satellite symposium, titled, Biosimilars: Your questions answered, which will address key questions regarding biosimilars and their impact on the management of rheumatoid arthritis. The symposium will take place between 8:15-9:45 on June 10, 2016 in Room 7, ICC Capital Suite of ExCeL London. Topics include:

• What do you think about biosimilars?
• How does Samsung Bioepis rapidly develop and manufacture high quality biosimilars?
• How are biosimilars regulated and monitored?
• How can clinicians interpret biosimilar studies?
• What if biologics were readily available?

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of 13 biosimilar candidates that include six first-wave product candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.

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