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sBLA based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: multi-switching group alternating between Humira and high-concentration HADLIMA vs. Humira-continued...

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...

Phase 3 study for SB17, Samsung Bioepis’ ustekinumab biosimilar candidate, demonstrates biosimilarity with reference ustekinumab through equivalent efficacy and comparable safety and pharmacokinetics...

Details the latest quarterly information on biosimilar utilization and financial datapoints for the US biosimilar marketExplores key determinants influencing various degrees of biosimilar utilization ...

Switching study conducted to evaluate whether switching from reference aflibercept to SB15 maintains comparable clinical efficacy and safetyPost-hoc analysis demonstrates biosimilarity between SB15...

Enters into a commercialization agreement for SB17, ustekinumab biosimilar candidate, in Europe and North America Partnership to support Samsung Bioepis pipeline expansion and provide increased...

INCHEON, South Korea and JERSEY CITY, N.J., Aug. 01, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced topline results from the interchangeability...

Details updated average sales price (ASP) trends and market share across all molecules for which biosimilars are availableIncludes Wholesale Acquisition Cost (WAC) trends of recently launched...

Highlights key initiatives that will drive the company’s transition towards a more sustainable businessReaffirms commitment to environmentally and socially responsible practices in R&D, clinical...

SB15 demonstrates comparable efficacy, safety, immunogenicity, and pharmacokinetics profiles to reference aflibercept up to Week 56Switching group had similar efficacy and safety compared to the...