Biogen, one of the world’s oldest independent biotechnology companies, 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 authorisation 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 authorisation 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.
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.
“The positive CHMP recommendation for Benepali is a great step forward for patients, physicians and payers in Europe. Biosimilars have the potential to help improve access to important biologic treatments for those who need them most,” said Alpna Seth, vice president and global head of the biosimilars business unit at Biogen.
“As a biotechnology leader with more than 35 years of experience in developing, manufacturing and commercialising advanced biologics, we look forward to bringing an array of anti-TNF biosimilar medicines to patients across Europe.”
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 3 clinical trials of Benepali compared to its reference product Enbrel. The 52-week, double-blind, phase 3 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 per cent in the Benepali arm versus 81.5 per cent in the Enbrel arm. The safety profile of Benepali was comparable to that of Enbrel.