Biosimilar Development News

  1. Aptevo Therapeutics To Receive Seven Year Quarterly Royalty Payment Stream From Pfizer For Sales Of Rituximab Biosimilar 6/25/2020

    Aptevo Therapeutics Inc., a biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR bispecific technology platform, today announced that it will receive a royalty from Pfizer related to sales of a rituximab biosimilar product, RUXIENCE (Rituximab-pvvr), which was approved by the U.S. Food and Drug Administration in July 2019 and launched by Pfizer in the United States and Japan in early 2020.

  2. The Biosimilars Forum To Provide Comment At FDA’s Annual Meeting On The Biosimilar User Fee Program 6/22/2020

    Today, the U.S. Food and Drug Administration (FDA) is hosting its annual meeting to review the financial management of multiple user fee programs, including the Biosimilar User Fee Act (BsUFA) II. 

  3. NMPA Accepts Bio-Thera Solutions’ Biologics License Application (BLA) For BAT1706, A Proposed Biosimilar To Avastin 6/19/2020

    Bio-Thera Solutions, a commercial-stage biopharmaceutical company, today announced that the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for BAT1706, a proposed biosimilar to Avastin (bevacizumab).

  4. TBRC Reports: Production Of New Insulin Biosimilars Is The Latest Trend In The Market, As Seen With Biocon's Newly FDA Approved Semglee 6/19/2020

    The production of new insulin biosimilars is trending in the biosimilars market, being produced to treat both type 1 and type 2 diabetes. As per reports in the Global Market Model, the key players operating in the biosimilars market are investing in creating biosimilars of insulin, which is promoting competition among various manufacturers.

  5. Innovent Announces The NMPA Granted Marketing Approval For BYVASDA® (Bevacizumab Biosimilar) In China 6/19/2020

    Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that BYVASDA® (bevacizumab biosimilar), a recombinant humanized anti-VEGF monoclonal antibody drug independently developed by Innovent, has been officially approved by the National Medical Products Administration (NMPA) of China for patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China.

  6. Phase 3 Trial Of Henlius Bevacizumab Biosimilar HLX04 In Metastatic Colorectal Cancer Met Study Primary Endpoint 6/16/2020

    Shanghai Henlius Biotech, Inc. today announced that the HLX04-mCRC03 study has successfully met the predefined primary endpoint. HLX04-mCRC03 is a randomized, double-blind, parallel-controlled, multi-centre phase 3 clinical trial comparing the efficacy, safety and immunogenicity of HLX04 (bevacizumab biosimilar) or bevacizumab (Avastin) in combination with oxaliplatin and fluoropyrimidine-based chemotherapy (XELOX or mFOLFOX6) as first-line treatment in patients with metastatic colorectal cancer (mCRC). 

  7. USP Releases Three New Monoclonal Antibody Reference Standards That Support Development Of Critical COVID-19 Treatments 6/15/2020

    Beginning Monday, June 15, the U.S. Pharmacopeia (USP) is donating samples of four monoclonal antibody (mAb) Reference Standards, including three new standards just released, to researchers developing mAb-based treatments for COVID-19.

  8. New Phase II Data Indicate Regimen Of Truxima (Biosimilar Rituximab), Lenalidomide And Acalabrutinib (R2A) May Be Well Tolerated And Effective In Relapsed/Refractory Aggressive B-Cell Lymphoma 6/14/2020

    Data presented as part of the Virtual Edition of the 25th EHA Annual Congress (EHA25 Virtual Congress) show that a regimen of Truxima (biosimilar rituximab), lenalidomide and acalabrutinib (R2A) may be well tolerated and effective in relapsed/refractory aggressive B-cell lymphoma.1

  9. Lannett Provides Update On Clinical Advancement Of Biosimilar Insulin Glargine, Following FDA Meeting 6/11/2020

    Lannett Company, Inc. (NYSE: LCI) today said that representatives from the company spoke with and received guidance from the U.S. Food and Drug Administration (FDA) on the clinical advancement program of its biosimilar insulin glargine partnered product candidate.

  10. FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, NYVEPRIA (pegfilgrastim-apgf) 6/11/2020

    Pfizer Inc. today announced the United States (U.S.) Food and Drug Administration (FDA) has approved NYVEPRIA (pegfilgrastim-apgf), a biosimilar to Neulasta (pegfilgrastim).1 NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.2