The reference product is approved in the European Union for use in moderate to severe rheumatoid arthritis (RA), ankylosing spondylitis, moderate to severe plaque psoriasis, active and progressive psoriatic arthritis.
It is also approved for use in moderate to severely active Crohn’s disease, and moderate to severely active ulcerative colitis.
Samsung Bioepis’ MAA is based on a preclinical and clinical data package comparing SB5 with Humira.
A Phase I study in healthy volunteers demonstrated pharmacokinetic bioequivalence to the reference product.
In a phase III study, SB5 demonstrated comparable efficacy, safety, and immunogenicity to Humira in patients with RA.
SB5 is the third anti-TNF-alpha biosimilar candidate submitted for review by Samsung Bioepis. Benepali (etanercept) was approved in January this year and Flixabi (infliximab) secured approval in May.
If approved, Biogen will oversee the marketing and distribution of SB5 in Europe.
Samsung Bioepis president & CEO Christopher Hansung Ko said: “If approved, SB5 will join Benepali and Flixabi in Europe, which have already started to increase patient access to high-quality treatment options while driving down healthcare spending.
“We will continue to work hard to advance one of the industry's largest biosimilar pipelines, so that more patients can access affordable medicines without any compromise in the quality of treatment.”