The European Commission (EC) yesterday announced its approval of the anti-TNF biosimilar for all indications of Humira, AbbVie’s lead monoclonal antibody which last year pulled in sales of over $16bn (€13.6bn) for the firm. It is the second version of Humira to be approved in Europe after Amgen saw regulatory success earlier this year.
The approval marks the fourth biosimilar success for the South Korean firm, following approvals of two other anti-TNF products Flixabi and Benepali – versions of J&J’s Remicade (infliximab) and Amgen’s Enbrel (etanercept), respectively – and its insulin glargine product Lusduna, a version of Sanofi’s Lantus.
“We are proud to become the industry’s first to obtain European approval for a third TNF inhibitor,” Samsung Bioepis CEO Christopher Hansung Ko said in a statement. “This is a testament to our agile biologics development platform, which has allowed us to develop approved biosimilars in less time at lower cost.”
But while the EC has given the thumbs up, Imraldi is unlilely to launch in Europe before AbbVie’s main patent expires in October 2018, by which time further biosimilars from firms including Boehringer Ingelheim and Sandoz could be approved.
Amgen received US Food and Drug Administration (FDA) approval for its adalimumab molecule Amjevita last September, but as yet Samsung Bioepis has not announced its own regulatory filing in the region.
Imraldi will be commercialised by Biogen which holds the marketing authority in Europe.
CORRECTION: The original story claimed Imraldi was the first Humira biosimilar to be approved in Europe. It is the second, after Amgen's Amgevita received EC approval in March.