Biosimilar Development News

  1. The Global Healthy Living Foundation Stands With The FDA And Its Biosimilar Education Efforts

    The Global Healthy Living Foundation, and its arthritis community, CreakyJoints, which represents millions of people with arthritis, strongly disagrees with last week’s public statement from the Patients for Biologics Safety & Access chiding the FDA for its efforts to educate providers about the critical role biosimilars play in today’s healthcare.

  2. CT-P13 (Biosimilar Infliximab) Is Comparable To Reference Infliximab And Adalimumab In Highly Anticipated Real-World Study

    Twelve-month data from the Personalised Anti-TNF therapy in Crohn’s disease Study (PANTS) was presented at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO). The results indicate that the clinical effectiveness, safety and immunogenicity of Celltrion Healthcare’s CT-P13 (biosimilar infliximab) in patients with Crohn’s disease (CD) is comparable to those treated with reference infliximab as well as those treated with adalimumab.

  3. Patient Groups Call On FDA To Provide More Complete And Robust Biosimilars Educational Materials For Prescribers

    Patients for Biologics Safety & Access (PBSA), a national coalition of more than 20 patient advocacy organizations, recently announced that it has submitted comments to the U.S. Food and Drug Administration (FDA) recommending changes to their online educational effort on biosimilars targeted to prescriber audiences.

  4. Oncology Biosimilar Industry Supply Chain Relationship, Development Trends, Key Companies Profile And Forecast To 2025 Published By Leading Research Firm
    2/14/2018 has added the report, “Oncology Biosimilar Market: Global Market Synopsis, Growth Factors, Industry Segmentation, Regional Analysis and Competitive Analysis 2017 – 2025” published by Reports Monitor.

  5. Celltrion Receives EU Approval For Trastuzumab Biosimilar

    Celltrion, Inc. announced recently that the European Commission (EC) approved Herzuma (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification.

  6. APAC Biosimilar Market, Forecast 2025

    Patent Expiries, Defined Regulatory Pathways, and Escalating Healthcare Costs to Boost Growth

  7. Biosimilars Forum Supports Inclusion Of Biosimilars In The Medicare Coverage Gap Discount Program

    The Biosimilars Forum supports inclusion of biosimilars in the Medicare Coverage Gap Discount Program (CGDP), or donut hole, as part of the 2018 Budget Agreement.

  8. Cate Lockhart Appointed Program Director Of Biologics And Biosimilars Collective Intelligence Consortium (BBCIC)

    The Biologics and Biosimilars Collective Intelligence Consortium is pleased to announce that Cate Lockhart, PharmD, PhD, has been appointed BBCIC Program Director. In this role, she will lead the development and growth of the multi-stakeholder research collaborative.

  9. The American College Of Rheumatology Recommends Biosimilar Use In New White Paper

    The American College of Rheumatology (ACR) has published a new white paper, “The Science Behind Biosimilars – Entering a New Era of Biologic Therapy,” providing a comprehensive overview of the scientific, clinical, economic and prescribing issues pertaining to biosimilar use, including efficacy, competition and drug pricing. The paper encourages providers to incorporate these drugs into treatment plans of patients with rheumatic diseases where appropriate.

  10. Lupin And Yoshindo's JV – YL Biologics Announces Successful Outcome Of Global Phase III Study For Etanercept Biosimilar In Rheumatoid Arthritis

    In their board meeting held at Pune last week, YL Biologics (YLB) announced that a global Phase III clinical trial of its investigational Etanercept biosimilar (YLB113) has met with successful outcome. YLB is the joint venture of Pharma major Lupin and Yoshindo in Japan.