Biosimilar Development News

  1. Lannett Announces Initiation Of Human Clinical Trial Of Biosimilar Insulin Glargine Versus Us Lantus®

    Lannett Company, Inc. (NYSE: LCI) today announced the commencement of a human clinical trial of biosimilar insulin glargine, a product the company is co-developing with its strategic alliance partners within the HEC Group of companies (HEC).

  2. Innovent Provides Key Results Update Of IBI305 (Biosimilar Product Candidate Of Bevacizumab) Compared With Bevacizumab

    Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines, today announced that the study results for efficacy and safety of IBI305 (biosimilar of bevacizumab) compared with bevacizumab in advanced, first-line, non-squamous NSCLC patients (NCT02954172) were presented by poster at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) [Abstract #9095; Sunday, June 2, 8:00 AM - 11:00 AM CDT].

  3. Strategic Biosimilar Development Partnership: STADA And Xbrane Strengthen Collaboration

    STADA Arzneimittel AG (“STADA”) and Xbrane Biopharma AB (“Xbrane”) have expanded their strategic biosimilar development partnership. This allows both companies to evaluate potential development and commercialization collaborations around Xbrane’s Xcimzane and Xdivane preclinical biosimilars and additional biosimilars that fit both companies’ portfolios.

  4. Pfenex And Alvogen Announce European Medicines Agency Accepts Marketing Authorization Application For PF708

    Pfenex Inc. (NYSE American: PFNX) and Alvogen today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) submitted by our partner Alvogen for PF708 (teriparatide).

  5. Biosimilars Forum Announces Support For Policies That Would Save Taxpayers And Seniors Billions

    The Biosimilars Forum recently released new scoring analysis, which it commissioned from Avalere Health, on three policy proposals to increase use of and patient access to biosimilars.

  6. European Medicines Agency Accepts Marketing Authorisation Application For Prestige BioPharma’s Trastuzumab Biosimilar HD201 For Review

    Prestige BioPharma (herein, Prestige) announced that European Medicines Agency (EMA) has validated and accepted for review the Marketing Authorization Application (MAA) for its trastuzumab biosimilar HD201 (Tuznue) on 23 May 2019.

  7. BC PharmaCare’s Biosimilars Initiative An Important Step Towards Improving Patient Access To Safe And Effective Medicines

    Sandoz Canada welcomes British Columbia (BC) PharmaCare’s announcement to implement the Biosimilars Initiative with the goal to expand the use of biosimilars available on the market and generate significant cost savings to the healthcare system.

  8. B.C. Expands Use Of Biosimilars To Offer Coverage For More Treatment Options

    British Columbia is improving the sustainability of its PharmaCare program by expanding the use of biosimilars, which will create opportunities for new drug listings and boost existing coverage for patients.

  9. Enzi, Hassan Introduce Bill To Improve Education Of Drug Products That Could Help Drive Down Costs

    U.S. Senators Mike Enzi, R-Wyo., and Maggie Hassan, D-N.H., introduced bipartisan legislation recently that would enhance education of biosimilar drug products in an effort to increase competition and lower the cost of biologic medicines.

  10. Celltrion Announces Approval Of Herzuma (trastuzumab-pkrb) In Brazil

    Celltrion announced the approval of Herzuma (project name: CT-P6, trastuzumab-pkrb), a mAb biosimilar for breast and gastric cancer, from the Brazilian Health Regulatory Agency, ANVISA (Agencia Nacional de Vigilancia Sanitaria) on May 20, 2019.