The 5th edition explores some IRA implications on biosimilars along with latest price trends, biosimilars market share Marks one year of providing quarterly updates on US biosimilar market trends ...
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 be randomized in a 1:1 ratio to receive either SB27 or Keytruda 200 mg intravenously every 3 weeks concurrently with chemotherapy (pemetrexed 500 mg/m2 with vitamin supplementation intravenous (IV) infusion over 10 minutes every 3 weeks and carboplatin area under the curve [AUC] 5 IV infusion over 15-60 minutes every 3 weeks for the first 4 cycles). More information on this study is available at clinicaltrials.gov (NCT06348199).
Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio
Report highlights latest biosimilar pricing and market share status, including state of the adalimumab marketBiosimilar Deep Dive section illustrates patient benefit from lower adalimumab cost options...
INCHEON, Korea, Nov. 30, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Johnson & Johnson settling all pending US patent litigation between...
As Johnson & Johnson’s top moneymaker Stelara nears its patent cliff, biosimilar makers are eager to launch their own versions of the blockbuster immunology med. Now, through a patent settlement, Samsung Bioepis becomes the latest company to score a license to market a Stelara biosim.
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...
INCHEON, Korea, Oct. 07, 2023 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. today announced that it presented a post-hoc analysis of the Phase 3 clinical study results for SB15, a proposed biosimilar to Eylea (aflibercept), at EURETINA 2023 being held from October 5 to 8 in Amsterdam, the Netherlands.