European regulators have approved the first biosimilar version of Pfizer/Amgen’s multi-billion-dollar anti-inflammatory therapy Enbrel, made by Samsung Bioepis, a joint venture between Samsung Biologics and Biogen.
Like its forerunner, Benepali (etanercept) has been cleared by the European Commission for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.
The approval, which comes after less than four years’ of development, centres on a 52-week Phase III clinical study showing comparable safety and equivalent efficacy to Enbrel, with ACR20 response rates of 80.8% versus 81.5%, respectively.
Availability of the drug “will drive down healthcare costs and increase patient access to one of the most widely used treatment options for immunological diseases across Europe,” said Samsung Bioepis’ chief executive Christopher Hansung Ko.
“Benepali’s affordability may allow more patients from a wider demographic to receive proper treatment, thereby enabling more people to live healthier, more comfortable lives,” noted Paul Emery, Arthritis Research UK Professor of Rheumatology at Leeds University, also highlighting the “impressive feat” of bringing the drug to market “with such speed, while ensuring the drug's high level of efficacy and safety”.
Benepali is to be “gradually rolled out” across all 28 European Union member states as well as in Norway, Iceland and Liechtenstein, with commercialisation and distribution lead by Biogen. First launches in the UK and Germany are expected to be in the “next few weeks” a spokesperson told PharmaTimes.
Novartis unit Sandoz filed its own biosimilar of the anti-TNF back in December, noting at the time that approval would enable more patients with enabling more patients with chronic inflammatory conditions such psoriasis and rheumatoid arthritis to be treated with biologics.