Biogen and Samsung Bioepis’ BYOOVIZ™ (ranibizumab-nuna) Launches in the United States
02 juin 2022 08h00 HE
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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)
31 mai 2022 18h05 HE
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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)
10 mars 2022 07h00 HE
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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
28 févr. 2022 04h40 HE
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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...
Samsung Bioepis Announces Health Canada Approval of 150mg Single-use Vial and 440mg Multi-dose Vial of ONTRUZANT® (SB3), Trastuzumab Biosimilar for the Treatment of Adults with Early Breast Cancer, Metastatic Breast Cancer, and Metastatic Gastric Cancer
02 févr. 2022 07h00 HE
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Samsung Bioepis
150mg and 440mg vial of ONTRUZANT® are now approved in CanadaONTRUZANT® becomes Samsung Bioepis’ fifth biosimilar to be approved in Canada in just six years INCHEON, Korea, Feb. 02, 2022 (GLOBE...
Samsung Bioepis Releases First Annual Sustainability Report
21 déc. 2021 05h00 HE
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Samsung Bioepis
Outlines the company’s Environment, Social and Governance (ESG) performance and commitment to becoming a socially responsible and sustainable companyAppoints dedicated ESG team to explore and...
Samsung Bioepis’ SB12 Soliris® (Eculizumab) Biosimilar Demonstrates PK, PD Bioequivalence in Phase 1 Study
11 déc. 2021 09h00 HE
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Samsung Bioepis
Phase 1 study demonstrated pharmacokinetics (PK) equivalence and comparable pharmacodynamic (PD), safety, immunogenicity profiles between SB12 and reference eculizumab INCHEON, Korea, Dec. 11,...
Longest Follow-Up Data on Trastuzumab Biosimilar Presented at 2021 SABCS
08 déc. 2021 18h00 HE
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Samsung Bioepis
Five-year follow-up results reconfirm comparable long-term efficacy of SB3 (ONTRUZANT®, trastuzumab-dttb) versus Herceptin® through additional analysis with a larger group of patients with...
New White Paper Highlights Barriers and Opportunities to Drive Biosimilar Adoption in the United States
17 nov. 2021 07h00 HE
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Samsung Bioepis
Healthcare professionals can benefit from more education to address knowledge gaps about the FDA’s robust evaluation, review, and approval standards for biosimilarsDo prescribers and patients benefit...
FDA Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab-nuna)
20 sept. 2021 07h30 HE
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Samsung Bioepis
BYOOVIZ™ becomes the first ophthalmology biosimilar to gain FDA approval in the United States INCHEON, Korea and CAMBRIDGE, Mass., Sept. 20, 2021 (GLOBE NEWSWIRE) -- Samsung Bioepis Co., Ltd. and...