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Samsung Bioepis enters European market with Benepali, first Enbrel biosimilar

18-01-2016 - http://www.thepharmaletter.com/ - The European Commission has approved Benepali – a biosimilar referencing Enbrel (etanercept) – 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 Benepaliby the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which was announced on November 20, 2015. Samsung Bioepis is a joint venture between US biotech firm Biogen (Nasdaq: BIIB) and South Korea’s Samsung Bioepis, and Benepali, a biosimilar of Amgen and Pfizer’s immunology drug.

“The approval of Benepali and its subsequent launches in Europe are major milestones for Samsung Bioepis,” said Christopher Hansung Ko, president and chief executive of Samsung Bioepis, adding: “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 III 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 member states as well as the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. Under 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.

Commercialization partnerships with Biogen and Merck & Co

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 & Co (NYSE: MRK), with whom Samsung Bioepis has commercialization agreements that cover the first six biosimilars in the company’s pipeline. The products and geographic responsibilities include:


  • SB4, investigational biosimilar candidate referencing Enbrel – European Union, Switzerland, Japan, bearing the trade name Brenzys;
  • SB2, investigational biosimilar candidate referencing Remicade (infliximab) – European Union, Switzerland, Russia, Turkey; and
  • SB5, investigational biosimilar candidate referencing Humira (adalimumab) – European Union, Switzerland, Russia, Turkey.

Merck & Co

  • SB4, investigational biosimilar candidate referencing Enbrel– Worldwide, but excluding the USA, EU, Switzerland, Japan;
  • SB2, investigational biosimilar candidate referencing Remicade – Worldwide, including the USA, but excluding the EU, Switzerland, Russia, Turkey;
  • SB5, investigational biosimilar candidate referencing Humira – Worldwide, including the USA, but excluding the EU, Switzerland, Russia, Turkey;
  • SB3, investigational biosimilar candidate referencing Herceptin (trastuzumab) – Worldwide; and
  • SB9 (MK-1293), investigational biosimilar candidate referencing Lantus (insulin glargine) – Worldwid
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