Positive Phase III outcomes from Samsung Bioepis’ biosimilar candidates

November 9, 2015 11:04 AM

Samsung Bioepis Co., Ltd. announced that SB4 etanercept and SB2 infliximab investigational biosimilar candidates sustained comparable safety profiles in 52- and 54-week clinical studies, respectively.

Equally important, SB5 adalimumab investigational biosimilar candidate demonstrated both equivalent efficacy and comparable safety in a 24-week Phase 3 clinical study.

The latest Phase 3 results for SB4, SB2 and SB5 will be presented at the upcoming 2015 Annual Meeting of the American College of Rheumatology (ACR) and the Association for Rheumatology Health Professionals (ARHP) in San Francisco.

“The one-year clinical studies for SB4 and SB2 investigational biosimilar candidates provide encouraging indications of their comparable safety profiles,” said Christopher Hansung Ko, CEO of Samsung Bioepis. “We will continue to focus on developing affordable biologic treatment options for patients who need these life-enhancing medications.”

The 52-week SB4 study, which randomized 596 patients across 70 sites in 10 countries, showed ACR20 response rate of 80.8% in the SB4 arm versus 81.5% in the Enbrel arm, fully supporting the 24-week study results of 78.1% and 80.3%, respectively.

The 54-week SB2 study, which randomized 584 patients across 73 sites in 11 countries, showed ACR20 response rate of 65.3% in the SB2 arm versus 69.2% in the Remicade arm, fully supporting the 30-week study results of 64.1% and 66.0%, respectively.

The 24-week Phase 3 study of SB5, which randomized 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy, showed ACR20 response rate of 72.5% in the SB5 arm versus 72.0% in the Humira arm. The safety profile of SB5 was comparable to Humira.

Samsung Bioepis has commercial agreements with Biogen and Merck to commercialize and distribute biosimilar products in immunology, oncology and diabetes. The products and geographic responsibilities include:

Biogen

  • SB4, investigational biosimilar candidate referencing Enbrel (etanercept) – European Union, Switzerland, Japan
  • SB2, investigational biosimilar candidate referencing Remicade (infliximab) – European Union, Switzerland, Russia, Turkey
  • SB5, investigational biosimilar candidate referencing Humira (adalimumab) – European Union, Switzerland, Russia, Turkey

Merck

  • SB4, investigational biosimilar candidate referencing Enbrel (etanercept) – Worldwide, but excluding United States, European Union, Switzerland, Japan
  • SB2, investigational biosimilar candidate referencing Remicade (infliximab) – Worldwide, including United States, but excluding European Union, Switzerland, Russia, Turkey
  • SB5, investigational biosimilar candidate referencing Humira (adalimumab) – Worldwide, including United States, but excluding European Union, Switzerland, Russia, Turkey
  • SB3, investigational biosimilar candidate referencing Herceptin (trastuzumab) –  Worldwide
    MK-1293, investigational biosimilar candidate referencing Lantus (insulin glargine) – Worldwide

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