SB4 (etanercept biosimilar) Phase III results for rheumatoid arthritis- Biogen + Samsung Bioepis
Biogen and Samsung Bioepis Co., Ltd announced that results from their anti-TNF biosimilar portfolio are being presented at the European League Against Rheumatism Annual Congress (EULAR 2015) in Rome, June 10�13, 2015. Highlights include results from separate head-to-head Phase III studies showing clinical comparability of SB4 (etanercept) and SB2 (infliximab), which are biosimilar development candidates to their respective reference products Enbrel and Remicade.
Also being presented are equivalence data from a Phase I pharmacokinetic (PK) study comparing SB5 (adalimumab), a biosimilar development candidate, with the reference product Humira. These results profile a promising anti-TNF biosimilar portfolio for the two companies.
The 24-week data from a Phase III study comparing SB4 with the etanercept reference product Enbrel in patients with moderate to severe rheumatoid arthritis, despite methotrexate therapy, showed equivalence in terms of clinical efficacy and safety.
Comment: SB 4 was filed by Samsung Bioepis + Biogen at EMA in January 2015.
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