In November last year, Samsung Bioepis received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use (CHMP) for its biosimilar version of Enbrel, and last week the European Commission (EC) gave the green light for its launch.
The approval was described a “milestone” for the joint venture by CEO Christopher Hansung Ko.
“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,”
The drug will be rolled out across all 28 European Union member states, plus Norway, Iceland and Liechtenstein, but a spokesman from the company was unable to comment on timelines or pricing discounts.
The biosimilar is made at Biogen’s plant in Hillerød, Denmark, using the same people and development processes as its originator products, a Biogen spokesperson previously told this publication.
As for commercialisation, Biogen will be responsible for Benepali across Europe and Japan, while Merck & Co. (known as MSD outside North America) will hold marketing authority in other markets (excluding US where Amgen has exclusivity until 2028).
Benepali is the first success for the Korean-based venture, which said in July it is considering launching itself on the NSDAQ Stock Exchange to raise cash for further biosimilar development.
The JV also has versions of J&J’s Remicade (infliximab), AbbVie’s Humira (adalimumab), Roche’s Herceptin (trastuzumab), and Sanofi’s Lantus (insulin glargine) in its pipeline.