EULAR: New data for three anti-TNF biosimilar development candidates

US biotech firm Biogen (Nasdaq: BIIB) and its South Korean joint venture Samsung Bioepis today released positive 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 Amgen’s (Nasdaq: AMGN) Enbrel and Johnson & Johnson’s (NYSE: JNJ) 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 AbbVie’s (NYSE: ABBV) Humira. These results profile a promising anti-TNF biosimilar portfolio for the two companies.

SB4 data highlights
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.