Biosimilar Development News

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. The Biosimilars Forum Commends Senate HELP Committee’s Effort To Educate Patients And Providers On Biosimilars

    Recently, the Senate Committee on Health, Education, Labor and Pensions (HELP) introduced a discussion draft that included guidelines to educate patients and providers about biosimilars.

  9. The Biosimilars Market Will Hit $69B By 2025: Global Market Insights, Inc.

    Recombinant glycosylated proteins segment of biosimilars market is estimated to grow at around 28.7% over the estimation period. Increase in number of people suffering from chronic disorders such as cancer and blood disorders will result in growing demand for biosimilars. Also, recent launch of molecular antibody biosimilars in developed regions of North America and Europe will boost the growth of recombinant glycosylated proteins over the forthcoming years.

  10. Alteogen Inc. Gets IND Approval For A Clinical Study In Korea For Eylea Biosimilar (ALT-L9)

    On May 22, Alteogen Inc. (CEO Soon Jae Park), a South Korean biotechnology company developing Eylea biosimilar (ALT-L9) to treat macular degeneration, announced that it gained Investigational New Drug (IND) approval for Phase 1 clinical trial from Ministry of Food and Drug Safety in Korea.