Despite mixed results for the therapy, drug companies are continuing to seek approval for new drugs in this field.
In November 2015 Samsung Bioepis announced that the European Medicines Agency’s committee for medicinal products in human use (CHMP) had expressed a positive opinion on Benepali, a biosimilar version of the biologic etanercept. The final decision on whether or not to approve the drug lies with the European Commission and, if marketing authorisation is granted, it will be the first etanercept biosimilar to be approved in the EU. The positive opinion was based on Phase 1 and Phase 3 clinical studies which tested Benepali against Enbrel. The company reported: “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.”
Samsung Bioepis is also at an advanced stage of development for two other biosimilar drugs for the treatment of rheumatoid arthritis and announced clinical trial results for both at the annual meeting of the American College of Rheumatology and the Association for Rheumatology Health Professionals in San Francisco in November 2015. Known as SB2 and SB5, the compounds are biosimilar to the approved biologics infliximab and adalimumab respectively. The SB2 study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries and showed comparable efficacy over 54 weeks. The SB5 study randomized 544 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 52 sites in seven countries over 24 weeks again showed comparable safety and equivalent efficacy to adalimumab, the company has announced.
Christopher Hansung Ko, CEO of Samsung Bioepis, said: “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.” Also in November 2015 American company Amgen went public on its Phase 3 trial of its biosimilar ABP 501 against adalimumab. Their figures claimed at week 24, 74.6 percent of patients in the ABP 501 group and 72.4 percent in the adalimumab group met the ACR20 response criteria. Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, said: “Demonstrating biosimilarity is scientifically complex, but Amgen’s 35 years of proven biologic R&D experience is facilitating the advancement of exciting programmesas like ABP 501. Our long-term commitment to advancing care in inflammation is as strong as ever, with a portfolio of novel and biosimilar compounds that have the potential to benefit patients worldwide.”
“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.” Christopher Hansung Ko, CEO of Samsung Biopics.