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.
References:
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
.
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