84 articles about Samsung Bioepis
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.
Biogen and Samsung Bioepis Heat Up the Lucrative AMD Market with First Biosimilar Approval
9/20/2021Three weeks after snagging approval in the UK, the U.S. FDA approved Samsung Bioepis and Biogen’s biosimilar drug. Byooviz is the first Lucentis copycat biologic to hit the market.
Samsung Bioepis Announces Analytical Similarity Data on SB11 (ranibizumab) at the ARVO Annual Meeting 2021
Analytical assessment demonstrates structural, physicochemical, and biological similarity between SB11 and Lucentis
Samsung Bioepis Continues Global Market Expansion with Launch of HADLIMA™ in Australia and Canada in partnership with Merck & Co.
Samsung Bioepis Co., Ltd. today announced its expansion of its global footprint to Australia with the launch of HADLIMA™ i (adalimumab), a biosimilar referencing HUMIRA ii(adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa and plaque psoriasis.
Samsung Bioepis Opens the New State-of-the-Art Headquarters to Accommodate Next Stage of Growth and Innovation
The 52,000-square-foot campus to become the hub of Samsung Bioepis’ drive for accelerated development of next-generation biologic medicines
Samsung Bioepis and Biogen Announce FDA Filing Acceptance of SB11, A Proposed Biosimilar Referencing Lucentis® (ranibizumab)
Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the U.S. Food and Drug Administration has accepted for review the Biologics License Application for SB11, a proposed biosimilar referencing Lucentis®.
Samsung Bioepis Announces First Real-World Data on RENFLEXIS® (infliximab-abda) with IBD patients from Veterans Affairs Healthcare System at the American College of Gastroenterology (ACG) 2020
Switching from reference infliximab or infliximab- dyyb to RENFLEXIS ® (infliximab- abda ) demonstrated comparable efficacy and safety in IBD patients registered to V A Healthcare System Continuation rates were similar for patients who underwent a single switch from reference infliximab to RENFLEXIS ® or double switch from reference infliximab to infliximab- dyyb to RENFLEXIS ® RENFLEXIS ®
Samsung Bioepis and Biogen Announce EMA Filing Acceptance of SB11, a Proposed Biosimilar Referencing Lucentis® (ranibizumab)
Samsung Bioepis Co., Ltd. and Biogen Inc. announced that the European Medicines Agency has accepted for review the Marketing Authorisation Application for SB11, a proposed biosimilar referencing Lucentis®.
Samsung Bioepis Announces 24-week Interim Results from a Phase 3 Trial of SB11, Proposed Ranibizumab Biosimilar
Samsung Bioepis Co., Ltd. announced that the primary endpoints have been met in the randomized, double-masked, phase 3 trial comparing the efficacy, safety and immunogenicity of SB11, a ranibizumab biosimilar candidate, to reference ranibizumab in patients with neovascular age-related macular degeneration.
Samsung Bioepis Announces Four-year Follow-up Data for Biosimilar ONTRUZANT® (trastuzumab-dttb) in Early or Locally Advanced HER2-positive Breast Cancer
Samsung Bioepis Announces Four-year Follow-up Data for Biosimilar ONTRUZANT ® (trastuzumab-dttb) in Early or Locally Advanced HER2-positive Breast Cancer Data to be presented at the ASCO20 Virtual Scientific Program Four-year event-free survival (EFS) and overall survival (OS) rates demonstrate biosimilarity between ONTRUZANT ® and reference trastuzumab INCHEON, Korea--( BUSINESS WIRE )-- Samsung Bioepis Co., Ltd. announced
Samsung Bioepis Announces US Launch of ONTRUZANT® (trastuzumab-dttb) for Early and Metastatic HER2-overexpressing Breast Cancer and Metastatic Gastric Cancer
Samsung Bioepis Co., Ltd. announced that ONTRUZANT®, a biosimilar of the reference biologic medicine HERCEPTIN®1 for the treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or gastroesophageal junction adenocarcinoma, is now available in the United States.
Samsung Bioepis Announces FDA Approval of 420 mg Multi-dose Vial of ONTRUZANT® (trastuzumab-dttb)
Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration has approved a 420 mg multi-dose vial of ONTRUZANT®, a biosimilar referencing HERCEPTIN®
Mundipharma Enters Partnership With Samsung Bioepis to Expand Biosimilars Into Hong Kong and Taiwan
Mundipharma announced a partnership with Samsung Bioepis to commercialize Samsung Bioepis' first-wave biosimilar candidates in Taiwan and Hong Kong.
FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate
Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration has accepted for review the company’s Biologics License Application under the 351 pathway for SB8, a biosimilar candidate referencing AVASTIN®i The BLA for SB8 was submitted by Samsung Bioepis in September 2019.
Samsung Bioepis Enters into Commercialization Agreement for Next-Generation Biosimilar Candidates
Agreement with Biogen covers Samsung Bioepis’ biosimilar candidates in pre-clinical and clinical development, which reference two widely-used biologic medicines in ophthalmology: ranibizumab and aflibercept
BioSpace Global Roundup, Oct. 10
10/10/2019Companies from across the globe provide updates on their business and pipelines.
Samsung Bioepis Presents Real-world Data of BENEPALI™ (etanercept) in Patients with Psoriasis at European Academy of Dermatology and Venereology (EADV) Congress
Real-world data from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR) shows that BENEPALI™ is effective in patients with psoriasis
Samsung Bioepis Announces Phase 3 Results of SB8, Bevacizumab Biosimilar Candidate, at the European Society for Medical Oncology (ESMO) 2019 Congress
Samsung Bioepis Co., Ltd. announced results from the Phase 3 study evaluating the efficacy and safety of SB8, a bevacizumab biosimilar candidate, compared to reference bevacizumab in patients with metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC).