Samsung Bioepis' SB4 (BRENZYS™) Becomes First Etanercept Biosimilar to Receive Regulatory Approval in Canada

Samsung Bioepis Co., Ltd. today announced that BRENZYS^™ – a biosimilar referencing Enbrel^® (etanercept), also known as SB4 – received regulatory approval in Canada for the treatment of rheumatoid arthritis and ankylosing spondylitis. BRENZYS^™ will be commercialized in Canada by Merck Canada Inc.

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“As evidenced in other markets, we believe BRENZYS will help drive down healthcare costs and increase patient access to one of the most widely used autoimmune treatment options in Canada,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “We remain committed to advancing one of the industry's largest biosimilar pipelines, so that more patients across Canada can access affordable, high-quality treatment.”

Prior to receiving approval in Canada, Samsung Bioepis’ SB4 etanercept biosimilar received regulatory approvals from Korea’s Ministry of Food and Drug Safety (MFDS) as BRENZYS^™ in September 2015, the European Commission (EC) as Benepali^® in January 2016 and Australia’s Therapeutic Goods Administration (TGA) as BRENZYS^™ in July 2016.

Samsung Bioepis is responsible for the development and manufacture of all immunology and oncology biosimilar candidates in its pipeline, including BRENZYS^™, as well as global clinical trials and regulatory registration in all markets worldwide for these biosimilar candidates. Following approval, Samsung Bioepis biosimilar products are marketed and distributed by its commercialization partners, Biogen and Merck, which is known as MSD outside the United States and Canada.

The regulatory submission for BRENZYS^™ was based on data from a randomized, double-blind 52-week Phase III study, involving 596 patients with moderate to severe rheumatoid arthritis across 70 sites in 10 countries, who were treated with either weekly dose of subcutaneous 50 mg SB4 or Enbrel^® with background methotrexate. At Week 52, SB4 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.

Samsung Bioepis Biosimilar Pipeline

Samsung Bioepis continues to advance a broad pipeline of 13 biosimilar candidates, which includes the following six first-wave candidates that cover the therapeutic areas of immunology, oncology and diabetes:

• SB4 biosimilar candidate referencing Enbrel^® (etanercept)ⁱ
• SB2 biosimilar candidate referencing Remicade^® (infliximab)ⁱⁱ
• SB5 biosimilar candidate referencing Humira^® (adalimumab)
• SB9 (MK-1293) biosimilar candidate referencing Lantus^® (insulin glargine)
• SB3 biosimilar candidate referencing Herceptin^® (trastuzumab)
• SB8 biosimilar candidate referencing Avastin^® (bevacizumab)

Commercialization of Samsung Bioepis Biosimilars

Samsung Bioepis is responsible for the development and manufacture of all immunology and oncology biosimilar candidates in its pipeline, as well as global clinical trials and regulatory registration in all markets worldwide for these biosimilar candidates. Following approval, Samsung Bioepis biosimilar products are marketed and distributed by its commercialization partners, Biogen and Merck, which is known as MSD outside the United States and Canada.

Manufacturing of Samsung Bioepis Biosimilars

Samsung Bioepis and Biogen have a manufacturing partnership for anti-TNF-α biosimilars, which brings together Samsung Bioepis’ technical leadership in manufacturing process development and Biogen’s rich heritage and expertise in manufacturing biologics. Samsung Bioepis’ biosimilars are manufactured in the same state-of-the-art drug substance facilities that have manufactured Biogen’s biologic medicines.

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 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.

ⁱ SB4 has received regulatory approval from Korea’s Ministry of Food and Drug Safety (MFDS) as BRENZYS ^™ , the European Commission (EC) as Benepali ^® , Australia’s Therapeutic Goods Administration (TGA) as BRENZYS ^™ and in Canada as BRENZYS ^™
ii SB2 has received regulatory approval from the MFDS as RENFLEXIS ^™ and the EMA as Flixabi ^® .

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Contact information

MEDIA CONTACT:
Samsung Bioepis Co., Ltd.
Mingi Hyun, +82-32-455-6128
mingi.hyun@samsung.com