Samsung Bioepis Presents Totality-of-the-Evidence Supporting Extrapolation of EPYSQLI™ (SB12; Eculizumab)’s Indication, at the European Society of Paediatric Nephrology (ESPN) 2024
23 sept. 2024 02h00 HE
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Samsung Bioepis
Samsung Bioepis Presents Totality-of-the-Evidence Supporting Extrapolation of EPYSQLI™ (SB12; Eculizumab)’s Indication, at the European Society of Paediatr
Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ™
20 sept. 2024 08h00 HE
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Samsung Bioepis
OPUVIZ™, a biosimilar referencing Eylea1 (aflibercept), is Samsung Bioepis and Biogen’s second ophthalmology biosimilar to be recommended for marketing authorization by the European Medicines Agency ...
FDA Approves Samsung Bioepis’ EPYSQLI® (eculizumab-aagh) as a Biosimilar to Soliris (eculizumab)
22 juil. 2024 07h00 HE
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Samsung Bioepis
Samsung Bioepis’ eighth biosimilar approved by the U.S. Food and Drug AdministrationEPYSQLI is approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical...
Samsung Bioepis Releases Third Quarter 2024 US Biosimilar Market Report
11 juil. 2024 08h00 HE
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Samsung Bioepis
Samsung Bioepis Releases Third Quarter 2024 US Biosimilar Market Report
FDA Approves PYZCHIVA® (ustekinumab-ttwe), Samsung Bioepis’ Biosimilar to Stelara
01 juil. 2024 02h03 HE
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Samsung Bioepis
PYZCHIVA becomes Samsung Bioepis’ seventh biosimilar and fourth immunology biosimilar approved by the FDAPYZCHIVA’s licensing period will begin on February 22, 2025, in the United States, based on the...
Samsung Bioepis Releases 2024 Sustainability Report, Highlighting Progress in Accessibility and R&D Innovation
25 juin 2024 09h00 HE
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Samsung Bioepis
Samsung Bioepis Releases 2024 Sustainability Report, Highlighting Progress in Accessibility and R&D Innovation
Samsung Bioepis Presents Post-hoc Analysis of Phase 3 Study for EPYSQLI™ (SB12; Eculizumab Biosimilar), at the European Hematology Association (EHA) Congress 2024
14 juin 2024 03h00 HE
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Samsung Bioepis
Samsung Bioepis Presents Post-hoc Analysis of Phase 3 Study for EPYSQLI™ (SB12; Eculizumab Biosimilar), at the European Hematology Association (EHA) Congre
Samsung Bioepis to Present Post-hoc Analysis of Phase 3 Study for EPYSQLI™ (SB12; Eculizumab Biosimilar), at the European Hematology Association (EHA) Congress 2024
30 mai 2024 02h30 HE
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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
27 mai 2024 04h00 HE
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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)
22 avr. 2024 01h00 HE
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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....