Biosimilar Development News

  1. European Medicines Agency Accepts Extension Marketing Authorisation Application for Review of Celltrion's Remsima SC, the Subcutaneous Version of Remsima

    Celltrion, Inc. today announced that the European Medicines Agency (EMA) has accepted for review of the Extension Marketing Authorisation Application for ‘Remsima SC’, the subcutaneous (SC) version of Remsima®, the autoimmune disease therapeutic antibody biosimilar of infliximab.

  2. Pfizer Reaches a Global Agreement with AbbVie

    Pfizer Inc. today announced that it has signed licensing agreements with AbbVie, resolving all global intellectual property matters for Pfizer’s proposed adalimumab biosimilar.

  3. Biosimilars Forum Announces Launch of Biosimilars Roundtable

    The Biosimilars Forum today announced the formation of the Biosimilars Roundtable, a working group dedicated to advancing biosimilar products and increasing access to biologic medicines. The Roundtable comprises nearly 40 stakeholder groups across the health care community, including patient advocates, physicians, pharmacists, payers, regulatory agencies and manufacturers.

  4. Coherent Market Insights Launches PHASE-XS, The First Exclusive Pipeline Database For Biologics And Biosimilars

    Coherent Market Insights, a market intelligence and consulting company, has developed PHASE-XS, a unique database and analytical platform providing critical analysis of clinical trials (Phase 3 and Phase 4) conducted in the U.S. It tracks more than 25 critical drug trial parameters, enabling detailed analysis for the clients.

  5. Daiichi Sankyo Launches Antitumor Agent Trastuzumab Biosimilar For Intravenous Drip Infusions 'Daiichi Sankyo' In Japan

    Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that it launched the antitumor agent trastuzumab BS for intravenous drip infusions 60 mg and 150 mg “Daiichi Sankyo” (generic name: trastuzumab (genetical recombination) [trastuzumab biosimilar 2], hereafter, “the product”) in Japan recently.

  6. Pharmaceutical Excipients Market Top Trends | The Industry Is Growing Significantly Along With Major Vendors

    "Global Pharmaceutical Excipients Market" Report of Market Research Future (MRFR)'s Explores Scope of the Study as Research Objective, Assumptions and Limitations in-depth. The report gives Market Dynamics by Major Drivers, Restraints, Opportunities and Challenges.

  7. Celltrion And Teva Announce FDA Approval Of TRUXIMA (rituximab-abbs), A Biosimilar To RITUXAN, For Three Non-Hodgkin’s Lymphoma Indications

    Celltrion, Inc. and Teva Pharmaceutical Industries Ltd. recently announced that the U.S. Food and Drug Administration (FDA) has approved TRUXIMA (rituximab-abbs), a monoclonal antibody (mAb) biosimilar to RITUXAN (rituximab) for the treatment of adult patients in three indications: Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non–Hodgkin’s lymphoma (NHL) as a single agent.

  8. Launch Of Agalsidase Beta BS I.V. Infusion [JCR] For Fabry Disease

    JCR Pharmaceuticals Co., Ltd announces recently that Agalsidase Beta BS I.V. Infusion 5mg and 35mg [JCR], approved in September 2018, is being placed on the National Health Insurance (NHI) reimbursement price list and launched as of today.

  9. FDA Approves First Biosimilar For Treatment Of Adult Patients With Non-Hodgkin's Lymphoma

    The U.S. Food and Drug Administration today approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin's lymphoma (NHL) to be used as a single agent or in combination with chemotherapy. Truxima is the first biosimiliar to be approved in the U.S. for the treatment of non-Hodgkin's lymphoma.

  10. Sandoz receives Eighth European Commission Approval For A Biosimilar With Ziextenzo (pegfilgrastim)

    Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the European Commission (EC) granted marketing authorization for biosimilar Ziextenzo® (pegfilgrastim).