Biosimilar Development News

  1. First Biotechnical Design Competition To Focus On Biosimilar Manufacturing Process
    9/21/2017

    Tiffany D. Rau, Ph.D., Senior Consultant at BioProcess Technology Consultants (BPTC), is an organizer of the First Annual Biotechnical Design Competition and a member of the four-judge panel at the Competition finals in October.

  2. Covance Discusses The US Market Access Landscape For Biosimilars
    9/20/2017

    SMi Group has announced that Mr John Carlsen, Vice President at Covance, has joined the speaker line-up for the 4th annual Biosimilars North America conference which takes place on November 15 & 16 in New Jersey.

  3. Pfizer Goes To Court To Allow Competition For Biologics And Expand Options For Patients
    9/20/2017

    To ensure patients and providers have access to important, lower cost biosimilar medicines, Pfizer recently filed suit in the U.S. District Court for the Eastern District of Pennsylvania against Johnson & Johnson (J&J).

  4. New Report Indicates Revising CMS Policy On Biosimilars Could Save $11.4B On Medicines Over 10 Years
    9/19/2017

    Recently, the Association for Accessible Medicines (AAM) and its Biosimilars Council released an analysis finding that if the Centers for Medicare & Medicaid Services (CMS) were to revise its current reimbursement policy for biosimilar medicines, the federal government could save $11.4B on medicines over the next 10 years.

  5. Genentech Receives Blow by FDA in Cancer Drug Avastin Biosimilar Battle, an Industrial Info News Alert
    9/18/2017

    Researched by Annette Kreuger, Industrial Info Resources --Biological drug maker Genentech, the developer of the blockbuster cancer drug Avastin, was dealt a stunning blow on September 14 when the U.S. Food and Drug Administration approved a biosimilar (generic biological drug).

  6. Celltrion Healthcare: Biosimilar Trastuzumab Candidate, CT-P6, Shown to Be Similar in Efficacy and Safety to Reference Trastuzumab in Breast Cancer Patients as Neoadjuvant and Adjuvant Treatment
    9/15/2017

    Celltrion Healthcare presents data at the European Society for Medical Oncology (ESMO) 2017 Congress that highlights similarity in efficacy and safety between CT-P6 (biosimilar trastuzumab candidate) and reference trastuzumab at both pre-operative (neoadjuvant) and post-operative (adjuvant) stages of treatment in patients with HER2-positive early breast cancer (EBC).1

  7. Boehringer Ingelheim Receives Positive CHMP Opinion For Adalimumab Biosimilar CYLTEZO
    9/15/2017

    Boehringer Ingelheim recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorisation Application of Cyltezo (adalimumab biosimilar), to treat multiple chronic inflammatory diseases in adults and children. The decision of the European Commission on the approval is expected in the fourth quarter of 2017.

  8. Samsung Bioepis First To Receive Positive CHMP Opinion On A Trastuzumab Biosimilar With ONTRUZANT
    9/15/2017

    Samsung Bioepis Co., Ltd. recently announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on ONTRUZANT, a biosimilar candidate referencing Herceptin (trastuzumab), for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

  9. Sandoz Proposed Biosimilar Adalimumab Matches Reference Biologic In Terms Of Efficacy And Safety In Long-Term Study
    9/14/2017

    Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announces new data on its proposed biosimilar adalimumab.

  10. Biosimilars Forum Opposes Current CMS Rule That Would Adversely Affect Biosimilars Development In The U.S.; Submits Comments On Appropriate Biosimilar Reimbursement Policy
    9/14/2017

    Recently, the Biosimilars Forum submitted comments on the Centers for Medicare & Medicaid Services' (CMS) proposed Medicare Physician Fee Schedule (MPFS) regarding biosimilar reimbursement policy that was finalized in 2016.