Ÿ In just under four years, Samsung Bioepis develops, tests and receives regulatory approval for Benepali®, the first etanercept biosimilar in the European Union
Ÿ The European Commission approval applies to all 28 European Union member states as well as the European Economic Area member states of Norway, Iceland and Liechtenstein.
INCHEON, Korea – January 17, 2016 – Samsung Bioepis Co., Ltd. today announced the European Commission's (EC) approval of Benepali® – a biosimilar referencing Enbrel® (etanercept), also known as SB4 – for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis. The EC approval follows a positive opinion on Benepali® by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP), which was announced on November 20, 2015.
"The approval of Benepali and its subsequent launches in Europe are major milestones for Samsung Bioepis," said Christopher Hansung Ko, President & CEO of Samsung Bioepis. "In just under four years, we successfully developed, tested and obtained regulatory approval for Benepali, a high-quality biologic medicine that will drive down healthcare costs and increase patient access to one of the most widely used treatment options for immunological diseases across Europe."
He added, "In addition to Benepali, we continue to advance one of the industry's broadest biosimilar pipelines with multiple biosimilar candidates in Phase 3 clinical trials. Over the coming months, a number of them will be filed for regulatory approval in markets across the world. We remain committed to leveraging our strengths in product development and quality assurance to bring affordable, high-quality medications to patients worldwide."
Benepali® will be gradually rolled out across all 28 European Union (EU) member states as well as the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. In accordance with a commercialization agreement signed in 2013 between Samsung Bioepis and Biogen, Biogen will lead the commercialization and distribution of Benepali® in the EU and EEA member states.
"Benepali gives physicians another high-quality medicine to treat autoimmune patients across Europe," said Paul Emery, Arthritis Research UK Professor of Rheumatology at Leeds University. "Benepali's affordability may allow more patients from a wider demographic to receive proper treatment, thereby enabling more people to live healthier, more comfortable lives. It is truly an impressive feat that Samsung Bioepis was able to bring Benepali to market with such speed, while ensuring the drug's high level of efficacy and safety."
In a 52-week Phase 3 clinical study, 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. The Benepali® study randomized 596 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 70 sites in 10 countries.
Commercialization Partnerships with Biogen and Merck
Samsung Bioepis is solely responsible for the development and manufacture of all immunology and oncology biosimilars in its pipeline, as well as global clinical trials and regulatory registration in all markets worldwide for these biosimilars. Following approval, Samsung Bioepis biosimilars are marketed and distributed by its commercialization partners, Biogen and Merck, with whom Samsung Bioepis has commercialization agreements that cover the first six biosimilars in the company's pipeline. The products and geographic responsibilities include:
Ÿ SB4, investigational biosimilar candidate referencing Enbrel® (etanercept) – European Union, Switzerland, Japan
Ÿ SB2, investigational biosimilar candidate referencing Remicade® (infliximab) – European Union, Switzerland, Russia, Turkey
Ÿ SB5, investigational biosimilar candidate referencing Humira® (adalimumab) – European Union, Switzerland, Russia, Turkey
Ÿ SB4, investigational biosimilar candidate referencing Enbrel® (etanercept) – Worldwide, but excluding United States, European Union, Switzerland, Japan
Ÿ SB2, investigational biosimilar candidate referencing Remicade® (infliximab) – Worldwide, including United States, but excluding European Union, Switzerland, Russia, Turkey
Ÿ SB5, investigational biosimilar candidate referencing Humira® (adalimumab) – Worldwide, including United States, but excluding European Union, Switzerland, Russia, Turkey
Ÿ SB3, investigational biosimilar candidate referencing Herceptin® (trastuzumab) – Worldwide
Ÿ SB9 (MK-1293), investigational biosimilar candidate referencing Lantus® (insulin glargine) – Worldwide
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to increasing patient access to affordable, high-quality biologic medicines. Through innovations in product development and quality assurance, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.