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
20 avr. 2023 07h00 HE
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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
17 avr. 2023 07h00 HE
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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™
31 mars 2023 08h00 HE
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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
17 mars 2023 07h00 HE
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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)
03 janv. 2023 07h00 HE
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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
03 nov. 2022 02h00 HE
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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
27 sept. 2022 12h01 HE
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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...
Samsung Bioepis Obtains Two ISO Certifications for Environmental Management System and Energy Management System
14 sept. 2022 03h00 HE
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Samsung Bioepis
Obtains ISO 14001 (Environmental Management System) and ISO 50001 (Energy Management System)Recognized for continuous practices and commitment to enhancing sustainability management INCHEON, Korea,...
Samsung Bioepis Presents Three-year Follow-up Data of Adalimumab Biosimilar SB5 in Patients with Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress
07 sept. 2022 02h01 HE
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Samsung Bioepis
Long term follow-up data from British Association of Dermatologics and Immunomodulators Register (BADBIR) shows safety and effectiveness of SB5 in patients with psoriasis who have started or...
Samsung Bioepis Presents New Phase 3 Study of SB12 (Eculizumab), A Proposed Biosimilar to Soliris, at the European Hematology Association (EHA) Congress 2022
10 juin 2022 03h01 HE
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Samsung Bioepis
Phase 3 study demonstrated clinical equivalence in efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of SB12 compared to reference eculizumab in paroxysmal nocturnal...