Momenta Pharma: J.P. Morgan Healthcare Conference (J&J) - Jan 16, 2016 - “M923 Meets Primary Endpoint in Human Pharmacokinetic (PK) Study”; “324 healthy volunteers randomized 1:1:1 to receive single 40 mg injection M923, US HUMIRA®, or EU HUMIRA, then followed for 71 days”; “PK bioequivalence demonstrated for all primary endpoints (Cmax, AUC0-inf and AUC0-336) across each pairwise comparison (M923/US HUMIRA, M923/EU HUMIRA and EU HUMIRA/US HUMIRA): Geometric LS mean ratios all close to unity (100%), 90% CIs well within the confidence bounds of 80.00-125.00% (range 93-113%)”; “Incidence of AEs and ADAs for M923 was similar to reference products”
Clinical data • Biosimilar
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