Samsung Bioepis

84 articles about Samsung Bioepis

• Samsung Bioepis’ SB12 Soliris® (Eculizumab) Biosimilar Demonstrates PK, PD Bioequivalence in Phase 1 Study

  12/11/2021

  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

  12/8/2021

  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

  11/17/2021

  Biologic medicines are among the most innovative drugs to treat many life-threatening conditions, including cancer and autoimmune diseases.

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  Biogen and Samsung Bioepis Heat Up the Lucrative AMD Market with First Biosimilar Approval

  9/20/2021

  Three 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

  5/1/2021

  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.

  3/29/2021

  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

  1/25/2021

  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)

  11/18/2020

  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

  10/26/2020

  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)

  10/6/2020

  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

  5/18/2020

  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

  5/15/2020

  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

  4/15/2020

  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)

  3/24/2020

  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

  1/13/2020

  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

  11/19/2019

  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

  11/6/2019

  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

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  BioSpace Global Roundup, Oct. 10

  10/10/2019

  Companies 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

  10/9/2019

  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

  9/26/2019

  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).