There has been one publication on SB4, an etanercept biosimilar, at the ACR 2015 Annual Meeting in San Francisco. SB4 has been developed by Samsung Bioepis. However, Hanwha Chemical’s HD203, also a biosimilar of etanercept, didn’t appear at the ACR 2015 Annual Meeting, which I think is strange as HD203 appeared at the ACR 2014 Annual Meeting with a phase 3 study.
Jiri Vencovsky and colleagues presented: “A Phase III, Randomized, Double-Blind Clinical Study Comparing SB4, an Etanercept Biosimilar, with Etanercept Reference Product (Enbrel®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (52-week Results)”. Conclusion: “Efficacy including radiographic progression and safety were comparable between SB4 and ETN [Enbrel] up to Week 52. The immunogenicity profile was lower in SB4 compared to ETN.”
SB4 will be marketed under the name of Benepali. What’s in a word: bene – good and the Tripitaka has been written in Pali. After the meeting the Committee for Medicinal Products for Human Use (CMPH) has recommended the European Medicines Agency (EMA) to approve Benepali. So, Samsung Bioepis now has the apply for approval. Benepali might be available in Europe in 2016. I did’t find anything on the status with the FDA.
Vencovsky J, Sylwestrzak A, Leszczyñski P, Porawska W, Baranauskaite A, Tseluyko V, Zhdan V, Stasiuk B, Milasiene R, Barrera Rodriguez AA, Cheong SY, Ghil J, Emery P. A Phase III, Randomized, Double-Blind Clinical Study Comparing SB4, an Etanercept Biosimilar, with Etanercept Reference Product (Enbrel®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (52-week Results) [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/a-phase-iii-randomized-double-blind-clinical-study-comparing-sb4-an-etanercept-biosimilar-with-etanercept-reference-product-enbrel-in-patients-with-moderate-to-severe-rheumatoid/. Accessed December 1, 2015.
Benepali and the Committee for Medicinal Products for Human Use - http://www.ema.europa.eu/docs/en_GB/document_library/Summary_of_opinion_-_Initial_authorisation/human/004007/WC500196736.pdf