Flixabi was submitted to the European Medicines Agency (EMA) in May last year and today the Agency’s Committee for Medicinal Products for Human Use (CHMP) gave the product a positive opinion, saying it meets requirements on the quality, efficacy and safety in comparison with the reference biologic Remicade.
The recommendation is the second for Samsung Bioepis - a JV between Biogen and Samsung Biologics – which received the regulatory thumbs up for Benepali, its biosimilar of Amgen’s Enbrel (etanercept), last November.
“The CHMP's positive opinion on Flixabi brings us a step closer to broadening affordable, high-quality treatment options for autoimmune patients across Europe,” said Christopher Hansung Ko, Samsung Bioepis’s CEO. The product has already received approval in Korea, under the brand Renflexis.
Benepali received European Commission (EC) approval in January, and while Samsung Bioepis will be hoping for a similar outcome for Flixabi over the coming weeks, the firm was unable to comment on any commercialisation plans.
The etanercept biosimilar drug substance is manufactured by partner Biogen at its plant in Hillerød, Denmark, and spokesman Mingi Hyun told Biopharma-Reporter Biogen would also be involved in the production of Flixabi.
“For each Samsung Bioepis biosimilar product, a number of CMO's are involved in the manufacturing process. Biogen is one of them.”
If approved, Flixabi will be marketed by Biogen and become the third infliximab biosimilar to be available across European markets, following the launches of Inflectra and Remsima in February 2015 by Hospira (now owned by Pfizer) and Celltrion, respectively. Both brands are technically the same drug product, made by Korean firm Celltrion.
It has been reported the use of Remicade biosimilars could save EU countries hundreds of millions of Euros over the next few years, and already such products have begun eating away at J&J’s reference biologic.
Remsima has already displaced Remicade as the market leader in Norway, and all but wiped out the reference product in Denmark, Steinar Madsen, director at the Norwegian Medicines Agency, said last October.