Samsung Bioepis Releases its Second US Biosimilar Market Report
July 11, 2023 07:00 ET
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Samsung Bioepis
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...
Samsung Bioepis Releases 2023 Sustainability Report
June 30, 2023 02:00 ET
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Samsung Bioepis
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...
1-Year Outcomes of Phase 3 Study for SB15, Proposed biosimilar to Eylea (aflibercept), Presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
April 24, 2023 18:30 ET
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Samsung Bioepis
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...
Samsung Bioepis to Present New Data for SB15, a proposed biosimilar to Eylea (aflibercept), at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
April 20, 2023 07:00 ET
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Samsung Bioepis
Final 56-week results from the Phase 3 study for SB15 compared with reference aflibercept in neovascular age-related macular degeneration to be presented, in addition to analytical similarity data...
Samsung Bioepis Releases its First US Biosimilar Market Report, Providing Insights on Pricing Trends and Usage Across Molecules
April 17, 2023 07:00 ET
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Samsung Bioepis
To be published on quarterly basis, with updated average sales price (ASP) and National Average Drug Acquisition Cost (NADAC) trendsBiosimilars continue to play a crucial role in driving down...
Samsung Bioepis Receives Positive CHMP Opinion for Eculizumab Biosimilar, EPYSQLI™
March 31, 2023 08:00 ET
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Samsung Bioepis
EPYSQLI™, a biosimilar referencing Soliris1 (eculizumab), is Samsung Bioepis’ first biosimilar in hematology to be recommended for marketing authorization by the European Medicines Agency INCHEON,...
Samsung Bioepis Presents Phase 1 Study Results of SB17 (Ustekinumab), A Proposed Biosimilar to Stelara, at 2023 AAD Annual Meeting
March 17, 2023 07:00 ET
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Samsung Bioepis
SB17 (ustekinumab) is Samsung Bioepis’s fourth biosimilar candidate in immunology pipeline, following SB4 (etanercept), SB2 (infliximab), and SB5 (adalimumab)Phase 1 study demonstrated...
Samsung Bioepis Announces Health Canada Approval of Citrate-Free High-Concentration of HUMIRA®¹ Biosimilar (adalimumab; SB5)
January 03, 2023 07:00 ET
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Samsung Bioepis
With the approval, Samsung Bioepis has both low (40mg/0.8mL) and high (40 mg/0.4mL) concentration of adalimumab biosimilar approved in CanadaReaffirms its commitment to increasing accessibility by...
Samsung Bioepis Wins ‘Company of the Year, Asia-Pacific’ Award at the Global Generics & Biosimilars Awards 2022
November 03, 2022 02:00 ET
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Samsung Bioepis
Recognized and awarded for its leadership and expertise in biosimilars – following 2020 Biosimilar Initiative of the Year awardAlso shortlisted as finalists in Company of the Year, Regulatory...
Samsung Bioepis Presents Data from its Ophthalmology Biosimilar Portfolio at American Academy of Ophthalmology (AAO) 2022 Annual Meeting
September 27, 2022 12:01 ET
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Samsung Bioepis
SB15, a proposed biosimilar to EYLEA, showed equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics profile to reference aflibercept in the Phase 3 study interim analysisA...