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...
Samsung Bioepis Obtains Two ISO Certifications for Environmental Management System and Energy Management System
September 14, 2022 03:00 ET
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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
September 07, 2022 02:01 ET
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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
June 10, 2022 03:01 ET
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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...
Biogen and Samsung Bioepis’ BYOOVIZ™ (ranibizumab-nuna) Launches in the United States
June 02, 2022 08:00 ET
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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...
Samsung Bioepis Announces New Data on Adalimumab Biosimilar, SB5 at the Annual European Congress of Rheumatology (EULAR 2022)
May 31, 2022 18:05 ET
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Samsung Bioepis
Samsung Bioepis and Biogen to present one abstract and one poster at EULAR 2022 on adalimumab biosimilar, SB5 including Phase 1 study of a new SB5 formulation and a pan-European real-world study,...
Health Canada Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab)
March 10, 2022 07:00 ET
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Samsung Bioepis
INCHEON, Korea and TORONTO, March 10, 2022 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and Biogen Canada Inc. today announced that Health Canada has approved BYOOVIZ™ – a biosimilar referencing...
Samsung Bioepis Celebrates 10 Years of Realizing Passion for Health, Innovating Patients Access Worldwide
February 28, 2022 04:40 ET
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Samsung Bioepis
Holds a virtual ceremonial event for the first time to mark the anniversary with its global employees Pledges to keep innovating access to biologic medicines worldwide INCHEON, Korea, Feb. 28, 2022...