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INCHEON, Korea, April 05, 2024 (GLOBE NEWSWIRE) Samsung Bioepis Co., Ltd. today announced the initiation of Phase 3 clinical trial for SB27, the company's proposed biosimilar referencing Keytrudai (pembrolizumab). The Phase 3 clinical trial for SB27 is a randomized, double-blind, parallel group, multicenter studyii to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB27 and Keytruda in patients with metastatic non-squamous non-small cell lung cancer. Patients will b ....
Interchangeability study for HADLIMA (adalimumab-bwwd) was conducted in accordance with the FDA’s Guidance for Industry; primary pharmacokinetics (PK) endpoints as well as efficacy, safety and immunogenicity profiles were comparable between switching group and continuous reference product Humira group 52-week results from SB17 Phase 3 study demonstrated long-term efficacy, safety, and immunogenicity of SB17 compared to reference ustekinumab, including switching from ustekinumab to SB17 INCHEON, ....
Phase 1 study for SB16, proposed biosimilar to Prolia, demonstrates pharmacokinetic (PK) bioequivalence between SB16, EU-sourced denosumab, and US-sourced denosumab in healthy male study participantsPhase 3 study shows ....
Details the latest quarterly information on biosimilar utilization and financial datapoints for the US biosimilar marketExplores key determinants influencing various degrees of biosimilar utilization ....
Legislation introduced by Utah Senator Mike Lee would eliminate testing to show a biosimilar can be substituted for a reference biologic product. Lee contends the current testing requirement adds costs and delays market access for these lower-cost biological medicines. ....