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EC approves Benepali – the first biosimilar of Enbrel

Posted: 18 January 2016 | | No comments yet

Benepali is the first etanercept biosimilar referencing Enbrel to be approved in the EU, making it the first subcutaneous anti-TNF biosimilar available there…

The joint venture between Biogen and Samsung BioLogics, Samsung Bioepis, has been granted European Commission (EC) approval for Benepali , an etanercept biosimilar referencing Amgen’s Enbrel.

enbrel

Benepali has been granted marketing authorisation in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. Biogen intends to make Benepali available for patients in the coming weeks.

Benepali is the first etanercept biosimilar referencing Enbrel to be approved in the EU, making it the first subcutaneous anti-TNF biosimilar available there. Anti-TNF’s are the largest component of the EU biologics market, accounting for approximately $10 billion of all biologics sold there.

Commenting on the announcement, Alpna Seth, Ph. D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen, said, “The approval of Benepali is a significant step forward for patients and physicians, and an important milestone for Biogen as we bring to market the first product from our biosimilar pipeline.”

Benepali had equivalent efficacy to Enbrel in trials

The EC approval was based on a robust preclinical and clinical data package. Confirmatory data from well-controlled, head-to-head Phase 1 and Phase 3 clinical trials compared Benepali to its reference product Enbrel. The 52-week, double-blind, Phase 3 study randomized 596 patients with moderate to severe RA despite methotrexate therapy, across more than 70 sites in 10 countries to receive Benepali or Enbrel in a 1:1 ratio. Analysis of the primary endpoint showed that Benepali had equivalent efficacy to Enbrel, as shown by an ACR20 response at week 24 of 78.1% in the Benepali arm versus 80.3% in the Enbrel arm. Further analysis at 52 weeks confirmed comparable efficacy as shown by an ACR20 response of 80.8% in the Benepali arm versus 81.5% in the Enbrel arm.

The safety profile of Benepali was comparable to that of Enbrel throughout the study.

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