CHMP recommends Benepali (etanercept biosimilar), biosimilar candidate to the reference product Enbrel- Biogen + Merck
Biogen announced further progress as part of its commitment to biosimilars. Samsung Bioepis, the joint venture between Samsung Biologics and Biogen, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization of Benepali (etanercept). Previously known as SB4, Benepali is a biosimilar candidate to the reference product Enbrel. The positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union (EU). If approved, Benepali could be the first biosimilar of Enbrel granted approval in the EU, as well as the first subcutaneous anti-TNF biosimilar there.
The CHMP’s positive opinion was based on a robust preclinical and clinical data package submitted to the EMA by Samsung Bioepis. The data in the preclinical submission leveraged sophisticated molecular analytics, technical development, and manufacturing expertise, together with confirmatory data from head-to-head Phase 1 and Phase III clinical trials of Benepali compared to its reference product Enbrel . The 52-week, double-blind, Phase III study randomized 596 patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy across 70 sites in 10 countries to receive Benepali or Enbrel in a 1:1 ratio. Results showed an ACR20 response rate of 80.8% in the Benepali arm versus 81.5% in the Enbrel arm. The safety profile of Benepali was comparable to that of Enbrel.
Comment: Benepali (etanercept) is an investigational treatment developed as a biosimilar to the reference product Enbrel. Pending EC review and approval, Benepali could be indicated for the treatment of moderate to severe RA, psoriatic arthritis, non-radiographic axial spondyloarthritis, and plaque psoriasis.
Comment: Enbrel patents according to Amgen cover etanercept until 2028 in the US; the patents expired in August 2015 in the EU.
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