Samsung Bioepis wins EMA nod for the first etanercept biosimilar in the European Union

November 23, 2015 7:14 AM

Samsung Bioepis Co., Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Benepali – a biosimilar version of Enbrel® (etanercept).

The drug, previously known as SB4 – for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis. This marks the first time the CHMP has adopted a positive opinion on an etanercept biosimilar.

The CHMP’s positive opinion will now be referred to the European Commission (EC) which will review and decide on the grant of a marketing authorization for Benepali®. If a marketing authorization is granted, Benepali will be the first etanercept biosimilar to be approved in the European Union (EU).

“We are very pleased to have developed the first etanercept biosimilar to receive a positive CHMP opinion,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “By leveraging our strengths in product development and quality assurance, we will continue to focus on developing affordable, high-quality biologic treatment options for patients in Europe who need these life-enhancing medications.”

This positive CHMP opinion on Benepali was based on Phase 1 and Phase 3 clinical studies that tested the biosimilarity of Benepali to Enbrel. In the 52-week Phase 3 clinical study, which involved 596 patients randomized across 70 sites in 10 countries, Benepali demonstrated comparable safety and equivalent efficacy to Enbrel, as evidenced in ACR20 response rate of 80.8% in the Benepali arm versus 81.5% in the Enbrel arm.

In addition to Benepali, Samsung Bioepis has been developing two other anti-tumor necrosis factor-alpha (anti-TNF-alfa) investigational biosimilar candidates, the latest clinical study results for which are as follows:

  • SB2 investigational biosimilar candidate to Remicade (infliximab): On November 9, 2015 at the Annual Meeting of the American College of Rheumatology (ACR) and the Association for Rheumatology Health Professionals (ARHP) in San Francisco, Samsung Bioepis announced 54-week SB2 clinical study results that showed comparable safety and equivalent efficacy to Remicade, as evidenced in ACR20 response rate of 65.3% in the SB2 arm versus 69.2% in the Remicade arm. The SB2 study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries. In March 2015, Samsung Bioepis submitted to the EMA a Marketing Authorization Application for SB2, for which a CHMP opinion has yet to be announced.
  • SB5 investigational biosimilar candidate to Humira (adalimumab): On November 10, 2015 at the ACR/ARHP Annual Meeting in San Francisco, Samsung Bioepis announced 24-week Phase 3 clinical study results that showed comparable safety and equivalent efficacy to Humira, as evidenced in ACR20 response rate of 72.5% in the SB5 arm versus 72.0% in the Humira arm. The study randomized 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 52 sites in seven countries.

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