Samsung Bioepis
107,Cheomdan-daero
Yeonsu-gu
Incheon
21987
Tel: 82-32-455-6114
Website: http://www.samsungbioepis.com/
Email: bioepisinfo@samsung.com
99 articles about Samsung Bioepis
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Samsung Invests in BrickBio to Develop Advanced Molecules and Therapies Using Protein Engineering Technology for Antibody-Drug Conjugates (ADC)
3/18/2024
Samsung Life Science Fund, created jointly between Samsung Biologics, Samsung Bioepis, and Samsung C&T, and managed by Samsung Ventures, and BrickBio, Inc. announced Samsung's investment in BrickBio, a preclinical-stage biopharmaceutical company focused on developing precision biologics using an expanded genetic code.
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Samsung Bioepis Presents Two Abstracts for Its Immunology Portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting
3/9/2024
Samsung Bioepis Co., Ltd. presented two new study results for its immunology portfolio – SB5, a biosimilar to Humira, and SB17, a proposed biosimilar to Stelara2 – at the 2024 American Academy of Dermatology Annual Meeting being held from March 8 to 12 in San Diego, California, United States.
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Despite offering discounts that reach as high as 85%, Humira biosimilars are finding it difficult to take market share away from the AbbVie blockbuster, according to a new report from Samsung Bioepis.
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Samsung Bioepis Releases First Quarter 2024 US Biosimilar Market Report
1/17/2024
Samsung Bioepis Co., Ltd. released its First Quarter 2024 Biosimilar Market Report which provides most timely information on the current status of biosimilars in the United States.
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The two companies have settled all pending U.S. patent litigation, clearing the way for commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of Stelara.
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Samsung Bioepis Secures US License Date for SB17, a Proposed Biosimilar to Stelara®
11/30/2023
Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Johnson & Johnson settling all pending US patent litigation between the two companies and clearing the way for commercialization of Samsung Bioepis’ SB17, a proposed biosimilar of reference medicine Stelara® in the United States.
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Samsung Bioepis & Organon Announce FDA Acceptance of Supplemental Biologics License Application (sBLA) for Interchangeability Designation for HADLIMA™ (adalimumab-bwwd), a Biosimilar to Humira®
11/7/2023
Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Supplemental Biologics License Application (sBLA) for the interchangeability designation for HADLIMA™ (adalimumab-bwwd) injection 40 mg/0.4 mL, a biosimilar to Humira® (adalimumab).
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Samsung Bioepis Presents Phase 1 and 3 Clinical Results for SB16, a Proposed Biosimilar to Proliaⁱ (denosumab), at ASBMR 2023
10/15/2023
Samsung Bioepis Co., Ltd. presented two clinical study data for SB16, a proposed biosimilar to Prolia, at the American Society for Bone and Mineral Research 2023 Annual Meeting being held from October 13 to 16 in Vancouver, BC, Canada.
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As the Novartis generics and biosimilars division nears its spin-off, Sandoz has signed a commercialization agreement with Samsung Bioepis, gaining rights to the latter’s Stelara biosimilar.
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Samsung Bioepis Partners with Sandoz to Commercialize Ustekinumab Biosimilar Candidate
9/11/2023
Samsung Bioepis Co., Ltd. announced that it has entered into a commercialization agreement with Sandoz for SB17, a proposed biosimilar to Stelarai, marking a step forward in strengthening access to Samsung Bioepis’ immunology portfolio in the United States, Canada, European Economic Area, Switzerland and United Kingdom.
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Samsung Bioepis & Organon Announce Topline Results from Interchangeability Study of SB5 Humira Biosimilar
8/1/2023
Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced topline results from the interchangeability study for SB5, a biosimilar to Humira ® (adalimumab).
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Samsung Bioepis Releases its Second US Biosimilar Market Report
7/11/2023
Samsung Bioepis Co., Ltd. released the second edition of its Biosimilar Market Report which explores latest market trends for all biosimilars commercially available in the United States.
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REPEAT/Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA™ (adalimumab-bwwd) in Multiple Presentations Consistent with Originator
7/5/2023
Organon & Co. & Samsung Bioepis Co., Ltd. announced that HADLIMA™, a biosimilar referencing Humira, is now available to patients in the United States.
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Organon & Samsung Bioepis Announce US Launch of HUMIRA Biosimilar HADLIMA™ (adalimumab-bwwd) in Multiple Presentations Consistent with Originator
7/1/2023
Organon & Co. & Samsung Bioepis Co., Ltd. announced that HADLIMA™, a biosimilar referencing Humira, is now available to patients in the United States.
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Samsung Bioepis Releases 2023 Sustainability Report
6/30/2023
Samsung Bioepis Co., Ltd. released its 2023 sustainability report, highlighting its progress toward building more sustainable and socially responsible practices in research and development, clinical trials, manufacturing, and supply chain management.
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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
4/24/2023
Samsung Bioepis Co., Ltd. today announced that 1-year outcomes of the Phase 3 study for SB15, a proposed biosimilar to Eylea1(aflibercept), were presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held from April 23 to 27, in New Orleans, Louisiana.
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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
4/20/2023
Samsung Bioepis Co., Ltd. today announced that it will present new data on SB15, a proposed biosimilar to Eylea 1 (aflibercept), at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.
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Samsung Bioepis Releases its First US Biosimilar Market Report, Providing Insights on Pricing Trends and Usage Across Molecules
4/17/2023
Samsung Bioepis Co., Ltd. released the first edition of its Biosimilar Market Report which explores latest market trends for all biosimilars commercially available in the United States.
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Samsung Bioepis Presents Phase 1 Study Results of SB17 (Ustekinumab), A Proposed Biosimilar to Stelara, at 2023 AAD Annual Meeting
3/17/2023
Samsung Bioepis Co., Ltd. today announced that SB17, a proposed biosimilar to Stelara 1 (ustekinumab), demonstrated pharmacokinetic (PK) bioequivalence and comparable safety, tolerability, and immunogenicity to reference ustekinumab in Phase 1 clinical study with healthy volunteers.
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Samsung Bioepis Announces Health Canada Approval of Citrate-Free High-Concentration of HUMIRA®¹ Biosimilar (adalimumab; SB5)
1/3/2023
Samsung Bioepis Co., Ltd. announced that Health Canada has approved HADLIMA™ - a citrate-free, high concentration formulation of biosimilar referencing HUMIRA®.