A research letter published by the British Journal of Dermatology from investigators in Samsung Bioepis’s biosimilar etanercept (SB4) clinical trials reports that, in addition to therapeutic equivalence between SB4 and reference etanercept (Enbrel), SB4 has been found to be less immunogenic than reference etanercept. The letter notes that injection site reactions—including rash, itching, and induration—occurred in 3.7% of study patients receiving SB4, compared to 17.5% of study patients receiving Enbrel. The presence of anti-drug antibodies was also assessed and found in 1.0% of study patients receiving SB4, compared to 13.1% of study patients receiving Enbrel.
The trial investigators also considered the correlation between injection site reactions and anti-drug antibodies. No correlation was identified.
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