Samsung Bioepis Announces New Data on Three Anti-TNF-α Biosimilar Molecules at the (EULAR 2016)

Samsung Bioepis Co., Ltd. today announced new clinical data on its anti-TNF-α portfolio of Benepali® (etanercept), Flixabi® (infliximab) and SB5 (adalimumab) investigational biosimilar candidate. The data will be presented through seven poster presentations and an abstract publication at the Annual European Congress on Rheumatology (EULAR 2016), which is being held between June 8-11, 2016 in London, United Kingdom. Samsung Bioepis will also operate a booth and host a satellite symposium. 

The poster presentations include switching data for the three Samsung Bioepis anti-TNF-α biosimilar molecules. The 100-, 78- and 52-week Phase III studies for Benepali®, Flixabi® and SB5, respectively, demonstrated comparable efficacy and safety profiles after transitioning from the reference product to the biosimilar version. 

“Payers and healthcare providers must be given sufficient clinical evidence, so that they can make informed decisions when deciding whether to switch to a biosimilar treatment option,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “Our clinical studies have demonstrated that transitioning from a reference product to its biosimilar version yields comparable outcomes with regards to both the efficacy and safety of treatment.” 

Chul Kim, Vice President and Head of the Medical & Lifecycle Safety Team at Samsung Bioepis, added, “Long-term clinical data is essential for anti-TNF-α medicines, as chronic patients suffering from autoimmune diseases require treatment over an extended period of time that can last many years. We hope that our new clinical evidence on switching, as well as long-term efficacy and safety, will assist physicians in their daily decision making process and ultimately help benefit the quality of patient care.” 

Highlights of the data are as follows: 

• Benepali® (etanercept), also known as SB4
  In a randomized, double-blind 100-week Phase III study, 596 patients with moderate to severe rheumatoid arthritis were treated with either weekly dose of subcutaneous 50 mg SB4 or etanercept with background methotrexate. After 52 weeks, 245 patients participated in the extension study. 126 patients continued to receive SB4 (SB4/ SB4) and 119 patients switched from etanercept to SB4 (etanercept/SB4). Among them, 119 (94.4%) patients of SB4/SB4 and 113 (95.0%) patients of etanercept/SB4 completed the 100-week treatment. At Week 100, the efficacy, safety and immunogenicity profiles remained comparable between SB4/SB4 and etanercept/SB4 with ACR20 response rates of 77.9% and 79.1%, respectively. There were no treatment emergent issues, such as loss of efficacy, increase in adverse events or increase in immunogenicity. 
• Flixabi® (infliximab), also known as SB2
  In a randomized, double-blind 78-week Phase III study, 584 patients with moderate to severe rheumatoid arthritis were randomized in a 1:1 ratio to receive either SB2 or infliximab. At Week 54, 396 patients were re-randomized. 94 patients from infliximab were transitioned to SB2 (infliximab/SB2), 101 patients from infliximab continued to receive infliximab (infliximab/infliximab) and 201 patients from SB2 continued to receive SB2 (SB2/SB2). Up to Week 78, the efficacy, safety and immunogenicity profiles remained comparable between the infliximab/SB2, infliximab/infliximab and SB2/SB2. There were no treatment emergent issues or clinically relevant immunogenicity. 
• SB5 (adalimumab) investigational biosimilar candidate
  In a 52-week Phase III study, 508 patients with rheumatoid arthritis were randomized in a 1:1 ratio to receive either SB5 or adalimumab 40 mg every other week via subcutaneous injection. At Week 24, 254 patients from SB5 continued to receive SB5 (SB5/SB5), 125 patients from adalimumab were transitioned to SB5 (adalimumab/SB5) and 129 patients from adalimumab continued to receive adalimumab (adalimumab/adalimumab). At Week 52, the efficacy, safety and immunogenicity profiles remained comparable between SB5/SB5, adalimumab/SB5 and adalimumab/adalimumab with ACR20 response rates of 76.9%, 81.1% and 71.2%, respectively. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by switching. After transition up to Week 52, the incidence of anti-drug antibody was 15.7% in SB5/SB5, 16.8% in adalimumab/SB5 and 18.3% in adalimumab/adalimumab. 

The seven poster presentations and one abstract publication are as follows: 

Benepali® (etanercept), also known as SB4 

• LONG-TERM SAFETY AND EFFICACY OF SB4 (ETANERCEPT BIOSIMILAR) IN PATIENTS WITH RHEUMATOID ARTHRITIS: COMPARISON BETWEEN CONTINUING SB4 AND SWITCHING FROM ETANERCEPT REFERENCE PRODUCT TO SB4 [POSTER SESSION: THU0150, June 9, 2016 at 11:45] 

Flixabi® (infliximab), also known as SB2 

• COMPARABLE SAFETY AND IMMUNOGENICITY AND SUSTAINED EFFICACY AFTER TRANSITION TO SB2 (AN INFLIXIMAB BIOSIMILAR) VS ONGOING INFLIXIMAB REFERENCE PRODUCT IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULTS OF PHASE III TRANSITION STUDY [POSTER TOUR: FRI0162, June 10, 2016 at 11:50] 
• EFFICACY AND SAFETY ANALYSIS BY OVERALL ANTI-DRUG ANTIBODY RESULTS UP TO WEEK 30 IN PATIENTS WITH RHEUMATOID ARTHRITIS TREATED WITH SB2 (AN INFLIXIMAB BIOSIMILAR) OR INFLIXIMAB REFERENCE PRODUCT IN PHASE III STUDY [POSTER SESSION: THU0140, June 9, 2016 at 11:45] 
• THE 54-WEEK RESULTS OF INTERFERON-Γ RELEASE ASSAY IN A PHASE III STUDY COMPARING SB2, AN INFLIXIMAB BIOSIMILAR, TO INFLIXIMAB REFERENCE PRODUCT IN PATIENTS WITH RHEUMATOID ARTHRITIS [POSTER SESSION: THU0149, June 9, 2016 at 11:45] 

SB5 (adalimumab) investigational biosimilar candidate 

• SUSTAINED EFFICACY AND COMPARABLE SAFETY AND IMMUNOGENICITY AFTER TRANSITION TO SB5 (AN ADALIMUMAB BIOSIMILAR) VS CONTINUATION OF THE ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH RHEUMATOID ARTHRITIS: RESULT OF PHASE III STUDY [POSTER TOUR: FRI0161, June 10, 2016 at 11:50] 
• SECONDARY EFFICACY RESULTS UP TO WEEK 24 FROM A PHASE III STUDY COMPARING SB5 (AN ADALIMUMAB BIOSIMIAR) WITH ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS DESPITE METHOTREXATE THERAPY [POSTER SESSION: THU0138, June 9, 2016 at 11:45] 
• IMPACT OF ANTI-DRUG ANTIBODIES ON EFFICACY AND SAFETY UP TO WEEK 24 FROM A PHASE III STUDY COMPARING SB5 (AN ADALIMUMAB BIOSIMILAR) WITH ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS DESPITE METHOTREXATE THERAPY [POSTER SESSION: THU0146, June 9, 2016 at 11:45] 
• A PHASE I PHARMACOKINETIC STUDY COMPARING PRE-FILLED PEN AND PRE-FILLED SYRINGE OF SB5, AN ADALIMUMAB BIOSIMILAR IN HEALTHY SUBJECTS [ABSTRACT PUBLICATION] 

Samsung Bioepis will operate a booth at the Annual European Congress on Rheumatology (EULAR 2016), where visitors can learn about the company. The booth will be located in Stand 200, Hall S16, South Event Halls (Level 1) of ExCeL London. 

Samsung Bioepis will also host a satellite symposium, titled, Biosimilars: Your questions answered, which will address key questions regarding biosimilars and their impact on the management of rheumatoid arthritis. The symposium will take place between 8:15-9:45 on June 10, 2016 in Room 7, ICC Capital Suite of ExCeL London. Topics include: 

• What do you think about biosimilars? 
• How does Samsung Bioepis rapidly develop and manufacture high quality biosimilars? 
• How are biosimilars regulated and monitored? 
• How can clinicians interpret biosimilar studies? 
• What if biologics were readily available?