Biosimilar Development News

  1. JHL Biotech Announces China Approves Phase I And Phase III Clinical Trial Application For Bevacizumab Biosimilar To Treat Cancer

    JHL Biotech announced today that the National Medical Products Administration of the PRC (NMPA) has approved JHL's Phase I and Phase III Clinical Trial Application for a proposed bevacizumab biosimilar, JHL1149, to treat several forms of cancer, including advanced non-squamous non-small-cell lung cancer (NSCLC), metastatic colorectal cancer, metastatic kidney cancer, advanced cervical cancer and recurrent ovarian cancer. JHL's China NMPA Phase III trial approval together with the UK MHRA trial approval mark the start of JHL's global Phase III clinical trial program.

  2. Amgen Launches AMGEVITA™ (Biosimilar Adalimumab) In Markets Across Europe

    Amgen (NASDAQ: AMGN) today announced that AMGEVITA™, a biosimilar to adalimumab, will launch in markets across Europe beginning on Oct. 16, 2018. AMGEVITA is the first adalimumab biosimilar to be approved by the European Commission (EC).

  3. Innovent Receives IND Approval To Initiate Clinical Trials In China With Sintilimab In Combination With Its Biosimilar To Bevacizumab

    Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, today announced that its IND application for a combination therapy of IBI308 (Sintilimab, an anti-PD-1 monoclonal antibody) and IBI305 (a biosimilar to the recombinant humanized anti-VEGF monoclonal antibody bevacizumab), has been approved by the National Medical Products Administration (NMPA, formerly known as CFDA) for clinical development.

  4. BIOCAD Expects To Make 50% Of Total Revenue From Export Activities By 2023

    The biotechnology company BIOCAD expects CPhI Worldwide to ensure a favorable climate for signing new distribution agreements with representatives of the pharmaceutical industries of Greece, UAE and Mexico.

  5. AbbVie Announces Global Resolution Of HUMIRA® (Adalimumab) Patent Disputes With Sandoz

    AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today a global resolution of all intellectual property-related litigation with Sandoz over its proposed biosimilar adalimumab product.

  6. New White Paper Finds Biosimilars Could Drive Greater Value Beyond Price For Healthcare System

    A new value assessment framework (VAF) can help patients, providers and payers understand how biosimilar treatments should be evaluated fully against their reference products, according to a white paper released today by the Biosimilars Forum.

  7. Sandoz Announces Global Resolution Of Biosimilar Adalimumab Patent Disputes, Securing Patient Access

    Sandoz, a Novartis division and the global leader in biosimilars, recently announced a global resolution of all intellectual property (IP) related litigation with AbbVie concerning the proposed Sandoz biosimilar Hyrimoz (adalimumab) for reference medicine Humira** (adalimumab).

  8. Celltrion And Teva Announce FDA Oncologic Drugs Advisory Committee Recommends Approval Of Celltrion BLA For CT-P10, A Proposed Rituximab Biosimilar

    Celltrion, Inc.  and Teva Pharmaceutical Industries Ltd. recently announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted unanimously 16-0 to recommend approval of CT-P10, a proposed monoclonal antibody (mAb) biosimilar to Rituxan (rituximab) for the treatment of adult patients in three proposed indications.

  9. Mundipharma Strengthens Position As A Leader In Biosimilars With Acquisition Of Development Company Cinfa Biotech

    The Mundipharma global network of independent associated companies has recently added development capabilities to its biosimilars platform with the purchase of biosimilars development company Cinfa Biotech.

  10. Fresenius Kabi’s Pegfilgrastim Biosimilar Candidate MSB11455 Met Its Primary Endpoints In The Two Pivotal Clinical Studies

    Fresenius Kabi announced recently that MSB11455, a biosimilar candidate of Neulasta (pegfilgrastim), met its primary endpoints in the two pivotal clinical studies. Both studies are designed to enable the application for marketing authorization in the EU and US.