Biosimilar Development News

  1. Enzi, Hassan Introduce Bill To Improve Education Of Drug Products That Could Help Drive Down Costs
    5/23/2019

    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.

  2. Celltrion Announces Approval Of Herzuma (trastuzumab-pkrb) In Brazil
    5/23/2019

    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.

  3. The Biosimilars Forum Commends Senate HELP Committee’s Effort To Educate Patients And Providers On Biosimilars
    5/23/2019

    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.

  4. The Biosimilars Market Will Hit $69B By 2025: Global Market Insights, Inc.
    5/22/2019

    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.

  5. Alteogen Inc. Gets IND Approval For A Clinical Study In Korea For Eylea Biosimilar (ALT-L9)
    5/22/2019

    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.

  6. Health Canada Approves Biocon And Mylan’s Ogivri, The First Trastuzumab Biosimilar, For The Treatment Of HER2-Positive Breast And Gastric Cancers
    5/22/2019

    Biocon Ltd. and Mylan N.V. recently announced that Health Canada has approved Mylan’s Ogivri (trastuzumab), a biosimilar to Herceptin (trastuzumab) co-developed with Biocon, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).

  7. NeuClone To Initiate Phase I Clinical Trial Of Stelara (Ustekinumab) Biosimilar, The Second Biosimilar From The 10-Product Portfolio With Serum Institute
    5/16/2019

    NeuClone Pharmaceuticals Ltd. (NeuClone), a clinical-stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products, today announced it will initiate the Phase I clinical trial of its Stelara® (ustekinumab) biosimilar in the second half of 2019.

  8. Mylan And Biocon To Present Final Overall Survival Data For Ogivri™ (trastuzumab-dkst), A Biosimilar To Herceptin®, At The American Society Of Clinical Oncology (ASCO) Annual Meeting
    5/15/2019

    Mylan N.V.(NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that final data from the HERITAGE study will be presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.

  9. Vizient Endorses Legislation To Empower The FTC To Challenge Prescription Drug Patent Abuses
    5/14/2019

    Vizient offered its formal endorsement of the Affordable Prescriptions for Patients Act. This bipartisan Senate legislation targets “patent thickets” and other patent abuses that brand name pharmaceutical manufacturers utilize to delay market competition from generic and biosimilar drugs.

  10. AbbVie Resolves HUMIRA® (adalimumab) U.S. Patent Litigation With Boehringer Ingelheim
    5/14/2019

    AbbVie (NYSE: ABBV) announced that it has resolved U.S. HUMIRA (adalimumab) litigation with Boehringer Ingelheim (BI). Under the terms of the resolution, AbbVie will grant BI a non-exclusive license to its HUMIRA-related intellectual property in the United States.