EMA committee gives Samsung Bioepis nod for Humira biosimilar Imraldi

The European Medicines Agency’s Committee for medicinal products for human use (CHMP) announced it has adopted a positive opinion on Imraldi, Samsung Bioepis’ biosimilar version of AbbVie’s best-selling monoclonal antibody Humira (adalimumab).

The endorsement “brings us a step closer to delivering a lower-cost, high-quality autoimmune treatment option to patients across Europe,” ​CEO Christopher Hansung Ko said in a statement today.

If Imraldi is now approved by the European Commission (EC) it will be the fourth biosimilar success on the continent for the South Korean firm – a collaboration between Samsung Biologics and Biogen.

The drug becomes the second version of Humira to be given a positive opinion by the EMA after the CHMP recommended Amgen’s adalimumab​ (under the two brands Amgevita and Solymbic) in January this year. Humira clocked in sales for AbbVie of over $16bn​ worldwide last year.

However, no biosimilar versions of Humira are likely to launch in Europe until AbbVie’s main patent expires in October 2018, at which time several other developers – potentially Boehringer Ingelheim​ and Sandoz​, from among over 30 adalimumab developers​ – may be preparing to compete in the space.

The news also edges Samsung Bioepis closer to becoming the first biosimilar company to gain European approval for versions of the ‘big three’ TNF (tumor necrosis factor) inhibitors, Humira, Remicade (infliximab)​ and Enbrel (etanercept)​.

If approved, Imraldi will be commercialised by Biogen which holds the marketing authority in Europe.