Biosimilar Development News

  1. Sandoz Enters Agreement For Proposed Trastuzumab Biosimilar, Currently In Phase III Development, To Treat Selected HER2-Positive Cancer Tumors
    4/30/2019

    Sandoz, a Novartis division and a global leader in biosimilars, today announced that it has entered into an agreement to commercialize a proposed trastuzumab biosimilar. This medicine is currently in Phase III clinical development for treatment of human epidermal growth factor receptor 2 positive (HER2+) breast and specific gastric cancer tumors.

  2. Samsung Bioepis expands autoimmune portfolio in the United States with FDA approval of ETICOVO (etanercept-ykro), a biosimilar referencing ENBREL (etanercept).
    4/29/2019

    Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved ETICOVO (etanercept-ykro), a biosimilar referencing ENBREL (etanercept), across all eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis. ETICOVO is Samsung Bioepis’ second anti-TNF biosimilar approved for marketing in the United States (US).

  3. FDA Approves ETICOVO (etanercept-ykro), Samsung Bioepis' Second Anti-TNF Medicine In The United States
    4/29/2019

    Samsung Bioepis Co., Ltd. recently announced that the US Food and Drug Administration (FDA) has approved ETICOVO (etanercept-ykro), a biosimilar referencing ENBREL (etanercept), across all eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis.

  4. EirGenix, Inc. Enters Into Global License Agreement For The Commercialization Of Its Biosimilar Drug EG12014
    4/29/2019

    EirGenix, Inc. announced today that it has entered into a license agreement with global generic and biosimilar drug manufacturer Sandoz AG, granting an exclusive license to Sandoz for right of commercialization of EirGenix 's breast cancer biosimilar drug, EG12014 (Trastuzumab Biosimilar to Roche / Genentech's Herceptin) globally with the exception of Taiwan and mainland China.

  5. Biosimilar Pipeline Analysis Market Detailed Industry Report Live Covering Players Biocon, Pfizer., F. Hoffmann-La Roche, Amgen, Boehringer Ingelheim GmbH, AstraZeneca, Novartis AG, And Merck
    4/26/2019

    Biosimilar is a type of biological product that is almost identical to the original product, which has undergone patent expiration. Development and validation of biosimilars are an important part of the overall production process.

  6. Henlius Trastuzumab HLX02 Filed New Drug Application
    4/26/2019

    Shanghai Henlius Biotech, Inc. has recently received a New Drug Application (NDA) acceptance from the National Medical Products Administration (NMPA) for its biosimilar HLX02, a trastuzumab for injection. 

  7. Xbrane Accelerates Development Of Xdivane – A Nivolumab (Opdivo) Biosimilar
    4/24/2019

    Xbrane Biopharma AB announces recently that the Company has successfully established a mammalian cell based technological platform and accelerate the development of Xdivane, a biosimilar of the PD-1 inhibitor Nivolumab (Opdivo) as the first product of this platform.

  8. Magellan Rx Management Biosimilar Program Shifts Infliximab Utilization By 86% In First Year, Resulting In 34% Drug Cost Savings
    4/16/2019

    Magellan Rx Management, the pharmacy benefit management (PBM) division of Magellan Health, Inc., released new data recently showcasing results from its medical pharmacy program focused on biosimilar management.

  9. Surge Of Indian Biosimilars Market Forecast In 2019
    4/16/2019

    New data from CPhI shows that, despite ongoing reputational challenges, India’s biologics market is set for robust growth in 2019 driven by biosimilars production.

  10. Biosimilars Market Size To Reach $26.7B By 2024: P&S Intelligence
    4/15/2019

    According to the market research report published by P&S Intelligence, biosimilars market is expected to generate $26.7 billion revenue by 2024, advancing at a CAGR of 29.6% during the forecast period. The market is majorly driven by rising prevalence of chronic diseases, increasing investment in research and development (R&D) activities by biopharmaceutical companies, extensive pipeline of biosimilars, growing geriatric population, and inexpensive nature of biosimilars as compared to reference drugs.