Biogen’s Enbrel biosimilar gets positive CHMP opinion
pharmafile | November 20, 2015 | News story | Research and Development, Sales and Marketing |
The Committee for Medicinal Products for Human Use (CHMP) today gave a positive opinion to Benepali- the first biosimilar version of Amgen’s rheumatoid arthritis blockbuster Enbrel (etanercept)- produced by Samsung Bioepis, the joint venture between Samsung Biologics and Biogen.
A positive opinion from the CHMP- an arm of the European Medicines Agency (EMA)- generally leads to later approval from the European Commission (EC), and so Biogen will be hopeful that marketing authorisation will be granted and that Benepali will become the first biosimilar of Enbrel granted approval in the EU, as well as the first subcutaneous anti-TNF biosimilar there.
Biogen said the announcement marked further progress as part of its commitment to biosimilars. Commenting on the decision, Alpna Seth, vice president and global head of the biosimilars business unit at Biogen, says: “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.
“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 preclinical and clinical data submitted to the EMA by Samsung Bioepis, comparing Benepali to its reference product Enbrel . The 52-week Phase 3 study randomised 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. ARC20 is the scale used to measure changes in the discomfort caused by rheumatoid arthritis.
Benepali was also found to have a comparable safety profile to that of Enbrel.
Pending EC review and approval, Biogen says Benepali could be indicated for the treatment of moderate to severe RA, psoriatic arthritis, non-radiographic axial spondyloarthritis, and plaque psoriasis.
Joel Levy
