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Samsung Bioepis Releases its First US Biosimilar Market Report, Providing Insights on Pricing Trends and Usage Across Molecules
April 17, 2023 07:00 ET | 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...
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Samsung Bioepis Receives Positive CHMP Opinion for Eculizumab Biosimilar, EPYSQLI™
March 31, 2023 08:00 ET | 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,...
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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 | 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...
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Samsung Bioepis Announces Health Canada Approval of Citrate-Free High-Concentration of HUMIRA®¹ Biosimilar (adalimumab; SB5)
January 03, 2023 07:00 ET | 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...
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Samsung Bioepis Wins ‘Company of the Year, Asia-Pacific’ Award at the Global Generics & Biosimilars Awards 2022
November 03, 2022 02:00 ET | 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...
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Samsung Bioepis Presents Data from its Ophthalmology Biosimilar Portfolio at American Academy of Ophthalmology (AAO) 2022 Annual Meeting
September 27, 2022 12:01 ET | 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...
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Samsung Bioepis Obtains Two ISO Certifications for Environmental Management System and Energy Management System
September 14, 2022 03:00 ET | 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,...
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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
September 07, 2022 02:01 ET | 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...
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Samsung Bioepis Presents New Phase 3 Study of SB12 (Eculizumab), A Proposed Biosimilar to Soliris, at the European Hematology Association (EHA) Congress 2022
June 10, 2022 03:01 ET | 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...
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Biogen and Samsung Bioepis’ BYOOVIZ™ (ranibizumab-nuna) Launches in the United States
June 02, 2022 08:00 ET | Samsung Bioepis
BYOOVIZ™ is the first FDA approved ophthalmology biosimilar BYOOVIZ, priced 40% lower than LUCENTIS®, provides an equally effective and more affordable treatment option to patients suffering from...