81 articles with Samsung Bioepis
Samsung Bioepis Presents Phase 1 Study Results of SB17 (Ustekinumab), A Proposed Biosimilar to Stelara, at 2023 AAD Annual Meeting
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.
Samsung Bioepis Announces Health Canada Approval of Citrate-Free High-Concentration of HUMIRA®¹ Biosimilar (adalimumab; SB5)
Samsung Bioepis Co., Ltd. announced that Health Canada has approved HADLIMA™ - a citrate-free, high concentration formulation of biosimilar referencing HUMIRA®.
Samsung Bioepis Wins ‘Company of the Year, Asia-Pacific’ Award at the Global Generics & Biosimilars Awards 2022
Samsung Bioepis Co., Ltd. announced the company has won ‘Company of the Year, Asia-Pacific’ at the ‘Global Generics & Biosimilars Awards 2022’ held on November 2, 2022 in Frankfurt, Germany.
Samsung Bioepis Presents Data from its Ophthalmology Biosimilar Portfolio at American Academy of Ophthalmology (AAO) 2022 Annual Meeting
Samsung Bioepis Co., Ltd. today announced that three scientific abstracts relating to its ophthalmology biosimilar portfolio will be presented at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting being held from September 30 to October 3, 2022 in Chicago, United States.
Samsung Bioepis Obtains Two ISO Certifications for Environmental Management System and Energy Management System
Samsung Bioepis Co., Ltd. announced that it has attained two ISO certifications: ISO 140001 and ISO 50001 from Lloyd’s Register Quality Assurance, reflecting the company’s ongoing practices and commitment to becoming a sustainable company.
The FDA is busy accepting drug applications, granting specialty designations and approving drugs for market. Here's a look at this week's FDA activity.
Biogen and Samsung Bioepis’ BYOOVIZ™ (ranibizumab-nuna) Launches in the United States
Biogen Inc. (Nasdaq: BIIB) and Samsung Bioepis Co., Ltd. today announced that BYOOVIZ™ (ranibizumab-nuna), a biosimilar referencing LUCENTIS® (ranibizumab)i has been launched in the United States.
Most of Samsung's investment will be in South Korea, and it expects to create 80,000 new jobs through 2026, or about 16,000 positions annually.
Samsung Biologics completes full acquisition of Samsung Bioepis
Samsung Biologics announced that it has completed the purchase of Biogen's stake in the Samsung Bioepis joint venture for USD $2.3 billion.
Health Canada Approves Samsung Bioepis and Biogen’s BYOOVIZ™ (SB11), LUCENTIS® Biosimilar (ranibizumab)
Samsung Bioepis Co., Ltd. and Biogen Canada Inc. announced that Health Canada has approved BYOOVIZ™ – a biosimilar referencing LUCENTIS®i – for the treatment of neovascular age-related macular degeneration.
AbbVie and Alvotech have settled a case, granting Alvotech a non-exclusive license to all Humira-related patents in the United States beginning on July 1, 2023.
Samsung Bioepis Announces Health Canada Approval of 150mg Single-use Vial and 440mg Multi-dose Vial of ONTRUZANT® (SB3)
Samsung Bioepis Co. Ltd. today announced that Health Canada has approved ONTRUZANT® (also known as SB3), a biosimilar referencing Herceptin®i (Trastuzumab), for the treatment of adults with Early Breast Cancer (EBC), Metastatic Breast Cancer (MBC) and metastatic gastric cancer (MGC).
Biogen is selling its nearly 50% stake in Samsung Bioepis for $2.3 billion. The move will provide Biogen with additional capital while preparing to cut additional costs through a rumored employee layoff.
Korea Economic Daily, published a story saying that Samsung Group was in talks to acquire Biogen. However, Samsung BioLogics stated in a regulatory filing yesterday that the rumor is not true.
Janssen Pharmaceutical says goodbye to San Francisco’s Theravance Biopharma after a disappointing performance from a drug the two companies were developing together.
Samsung Bioepis Releases First Annual Sustainability Report
Outlines the company’s Environment, Social and Governance (ESG) performance and commitment to becoming a socially responsible and sustainable company.
Shares of Coherus BioSciences are climbing in premarket trading after the company announced the FDA greenlit the company’s Humira biosimilar Yusimry.
Samsung Bioepis’ SB12 Soliris® (Eculizumab) Biosimilar Demonstrates PK, PD Bioequivalence in Phase 1 Study
Samsung Bioepis Co., Ltd. announced that SB12, a proposed biosimilar to Soliris®i, met all the endpoints in the Phase 1 study that evaluated PK, PD, safety, tolerability, and immunogenicity profiles between SB12 and reference eculizumab in healthy volunteers.
Longest Follow-Up Data on Trastuzumab Biosimilar Presented at 2021 SABCS
Samsung Bioepis Co., Ltd. today announced that SB3 (ONTRUZANT®, trastuzumab-dttb), a biosimilar to Herceptin® (trastuzumab), demonstrated comparable long-term survival results between SB3 and reference trastuzumab (TRZ) after a median follow-up of 68 months from the randomization of the SB3 Phase 3 study.
New White Paper Highlights Barriers and Opportunities to Drive Biosimilar Adoption in the United States
Biologic medicines are among the most innovative drugs to treat many life-threatening conditions, including cancer and autoimmune diseases.