Samsung Highlights New Biosimilar Switching Data At EULAR
This article was originally published in PharmAsia News
Executive Summary
South Korea's Samsung Bioepis, which is tapping the US market with its infliximab biosimilar, has presented new clinical switching data for its etanercept product Benepali, its infliximab biosimilar Flixabi, and SB5, an investigational version of adalimumab, at the annual European Congress on Rheumatology.
SEOUL - Samsung Bioepis Co. Ltd. said new switching data on its anti-TNF-α biosimilar portfolio - Benepali, Flixabi and SB5 - show sustained comparable efficacy and safety profiles after switching from the original branded reference products.
The company presented the new studies, including the switching data for the three Samsung Bioepis anti-TNF-α biosimilar molecules, through poster presentations and an abstract at the EULAR 2016 meeting held in London on June 8-11.
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 and 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.”
Highlights of the new data are as follows.
1) Benepali (etanercept, also known as SB4): In a 100-week Phase III study, 596 patients with moderate to severe rheumatoid arthritis were treated with either weekly dose of subcutaneous 50mg 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). 119 (94.4%) patients of SB4/SB4 and 113 (95.0%) patients of etanercept/SB4 completed the 100-week treatment. At week 100, 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.
2) Flixabi (infliximab, also known as SB2): In a 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.
3) SB5 (adalimumab): 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 40mg 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.
Chul Kim, vice president and head of the Medical & Lifecycle Safety Team at Samsung Bioepis, noted that “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.”
Rapid Pipeline Progress
The company, which is a joint venture between Samsung BioLogics and Biogen Inc., has been rapidly progressing development of its 13 biosimilar candidates. Its six “first-wave” products cover the therapeutic areas of immunology, oncology and diabetes.
In May, the US FDA accepted for review Samsung Bioepis's biologics license application (BLA) for SB2, a biosimilar version of Johnson & Johnson's Remicade, for the intended treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis (Also see "Samsung Bioepis Taps Infliximab As Its US Biosimilar Pioneer" - Scrip, 24 May, 2016.). SB2 is the first of Samsung Bioepis' biosimilar candidates to be submitted for review in the US.
Celltrion Inc./Pfizer Inc. expect to launch their biosimilar product Inflectra (infliximab-dyyb) in the US in September pending resolution of a legal dispute (Also see "Celltrion/Pfizer Agree To Wait For Mid-Sept US Inflectra Launch" - Scrip, 10 Jun, 2016.).
Informa’s Datamonitor Healthcare
analyst Tijana Ignjatovic told PharmAsia News that the previous ground-breaking approval of Inflectra should “make the regulatory process [for SB2] easier and faster, as there is a precedent especially with regard to indication extrapolation.”
In terms of competing and uptake in general, “the key things will be pricing and getting onto payers’ formularies,” along with detailing and education to ensure physicians accept the product.
Samsung's infliximab biosimilar has already received regulatory approval from South Korean authorities as Renflexis late last year. In late May, the European Commission also approved SB2 as Flixabi for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
Its biosimilar etanercept is already available in South Korea and Europe.