Samsung Bioepis close to major EU approval for Enbrel biosimilar
- The European Medicines Agency (EMA) is recommending Benepali (biosimilar Enbrel) be approved for arthritis, psoriasis, and ankylosing spondylitis.
- Amgen and Pfizer jointly market Enbrel (etenercept), which generated roughly $2.5 billion in revenues last year.
- Samsung Bioepis is a joint venture between Samsung and Biogen.
A little more than two months ago, Samsung Bioepis won its first approval ever—an approval in Korea for the team's biosimilar version of Enbrel. It appears there may be more forthcoming. Currently, the team has joined Merck to develop biosimilar versions of Remicade, Humira, and Herceptin.
Based on the partnership deal, Merck has co-marketing rights to all of the drugs (including Benepali) in specific territories and regions worldwide.
In the U.S., Novartis is also working on a version of Enbrel, eyeing potential approval in 2016; however, Amgen hopes to enforce patent rights based on a new 2011 patent, arguing it protects Enbrel in the U.S. through 2029.
Future patent conflicts can be expected in the U.S. as the domestic biosimilar market is still developing and is roughly 10 years behind other markets. The E.U. market gives the industry here a glimpse at what the future of biosimilars may bring.