Biogen receives CHMP backing for biosimilar Benepali

Biogen has announced that its new biosimilar product Benepali has been recommended for European regulatory approval.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on approval of the therapy, developed as a biosimilar to the reference product Enbrel.

Data from clinical trials has demonstrated that Benepali offers comparable safety and efficacy to the original therapy. If approved, it could be used as a treatment for moderate to severe rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis.

Benepali could become the first biosimilar of Enbrel and the first subcutaneous anti-TNF biosimilar granted approval in the EU.

Alpna Seth, vice-president and global head of the biosimilars business unit at Biogen, said: "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."

The drug's development has been overseen by Samsung Bioepis, a joint venture between Samsung Biologics and Biogen established in 2012.