Samsung Bioepis to Present Post-hoc Analysis of Phase 3 Study for EPYSQLI™ (SB12; Eculizumab Biosimilar), at the European Hematology Association (EHA) Congress 2024
May 30, 2024 02:30 ET
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Samsung Bioepis
Post-hoc analysis of Phase 3 study to highlight transfusion avoidance results of SB12 compared to reference eculizumab-treated groups INCHEON, Korea, May 30, 2024 (GLOBE NEWSWIRE) -- Samsung...
Samsung Bioepis Announces Oral Presentation on Switching Period Results for SB16, a Proposed Biosimilar to Prolia (Denosumab) at the European Calcified Tissue Society (ECTS) Congress 2024
May 27, 2024 04:00 ET
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Samsung Bioepis
Follow-up results from Phase 3 study on SB16: switching period up to Month 18Study shows SB16 comparable with reference denosumab before and after switching in terms of efficacy, pharmacokinetics,...
Samsung Bioepis Gains European Commission Approval For PYZCHIVA™, a Biosimilar to Stelara (Ustekinumab)
April 22, 2024 01:00 ET
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Samsung Bioepis
PYZCHIVA becomes Samsung Bioepis’ fourth EC-approved immunology biosimilar Sandoz to commercialize PYZCHIVA in Europe INCHEON, Korea, April 22, 2024 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd....
Samsung Bioepis Releases Second Quarter 2024 US Biosimilar Market Report
April 08, 2024 07:00 ET
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Samsung Bioepis
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 ...
Samsung Bioepis Initiates Phase 3 Clinical Trial for SB27, Proposed Biosimilar to Keytruda (Pembrolizumab)
April 05, 2024 01:00 ET
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Samsung Bioepis
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...
Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting
March 09, 2024 10:05 ET
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Samsung Bioepis
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...
Samsung Bioepis Releases First Quarter 2024 US Biosimilar Market Report
January 17, 2024 02:00 ET
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Samsung Bioepis
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...
Samsung Bioepis Secures US License Date for SB17, a Proposed Biosimilar to Stelara®
November 30, 2023 01:00 ET
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Samsung Bioepis
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...
Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a Biosimilar to Humira®
November 07, 2023 16:15 ET
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Samsung Bioepis
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...
Samsung Bioepis Presents Phase 1 and 3 Clinical Results for SB16, a Proposed Biosimilar to Proliaⁱ (denosumab), at ASBMR 2023
October 15, 2023 19:00 ET
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Samsung Bioepis
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...