Samsung Bioepis Receives Positive CHMP Opinion for the First Etanercept Biosimilar in the European Union

Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Benepali^® – a biosimilar version of Enbrel^® (etanercept), previously known as SB4 – for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis. This marks the first time the CHMP has adopted a positive opinion on an etanercept biosimilar.

The CHMP’s positive opinion will now be referred to the European Commission (EC) which will review and decide on the grant of a marketing authorization for Benepali^®. If a marketing authorization is granted, Benepali^® will be the first etanercept biosimilar to be approved in the European Union (EU).

“We are very pleased to have developed the first etanercept biosimilar to receive a positive CHMP opinion,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “By leveraging our strengths in product development and quality assurance, we will continue to focus on developing affordable, high-quality biologic treatment options for patients in Europe who need these life-enhancing medications.”

This positive CHMP opinion on Benepali^® was based on Phase 1 and Phase 3 clinical studies that tested the biosimilarity of Benepali^® to Enbrel^®. In the 52-week Phase 3 clinical study, which involved 596 patients randomized across 70 sites in 10 countries, Benepali^® demonstrated comparable safety and equivalent efficacy to Enbrel^®, as evidenced in ACR20 response rate of 80.8% in the Benepali^® arm versus 81.5% in the Enbrel^® arm.

In addition to Benepali^®, Samsung Bioepis has been developing two other anti-tumor necrosis factor-alpha (anti-TNF-α) investigational biosimilar candidates, the latest clinical study results for which are as follows:

• SB2 investigational biosimilar candidate to Remicade ^® (infliximab): On November 9, 2015 at the Annual Meeting of the American College of Rheumatology (ACR) and the Association for Rheumatology Health Professionals (ARHP) in San Francisco, Samsung Bioepis announced 54-week SB2 clinical study results that showed comparable safety and equivalent efficacy to Remicade^®, as evidenced in ACR20 response rate of 65.3% in the SB2 arm versus 69.2% in the Remicade^® arm. The SB2 study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries. In March 2015, Samsung Bioepis submitted to the EMA a Marketing Authorization Application for SB2, for which a CHMP opinion has yet to be announced.
• SB5 investigational biosimilar candidate to Humira ^® (adalimumab): On November 10, 2015 at the ACR/ARHP Annual Meeting in San Francisco, Samsung Bioepis announced 24-week Phase 3 clinical study results that showed comparable safety and equivalent efficacy to Humira^®, as evidenced in ACR20 response rate of 72.5% in the SB5 arm versus 72.0% in the Humira^® arm. The study randomized 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 52 sites in seven countries.

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 and oncology. 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

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

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Contact information

Samsung Bioepis Co., Ltd.
MEDIA CONTACT:
Mingi Hyun, +82-32-455-6128
mingi.hyun@samsung.com
INVESTOR CONTACT:
Sungjoon Park, +82-32-455-6120
sj4.park@samsung.com