Samsung Bioepis Co., Ltd, a biopharmaceutical company, 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 per cent in the Benepali arm versus 81.5 per cent 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.
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:
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
SB9 (MK-1293), investigational biosimilar candidate referencing Lantus (insulin glargine) – worldwide