Biosimilar Development News

  1. Pfizer Receives U.S. FDA Approval For Its Oncology Biosimilar, ZIRABEV (bevacizumab-bvzr)

    Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration(FDA) has approved ZIRABEV (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.

  2. NMPA Accepts New Drug Application For IBI301, A Biosimilar Product Candidate Of Rituximab (MabThera/Rituxan)

    Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Eli Lilly and Company ("Lilly") jointly announced today that the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for IBI301, a co-developed biosimilar product candidate of rituximab (MabThera/Rituxan).

  3. Pharmacy Times Continuing Education Presents The American Journal Of Managed Care (AJMC®) Payer And Specialty Pharmacy Forum: Improving The Adoption Of Oncology Biosimilars In Practice

    Pharmacy Times Continuing Education (PTCE), a leader in continuing education for retail, health-system, managed care, and specialty pharmacists, launches The American Journal of Managed Care (AJMC) Payer and Specialty Pharmacy Forum: Improving the Adoption of Oncology Biosimilars in Practice.

  4. Patent Thickets Bog Down U.S. Biosimilar Launches

    The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), recently released a white paper finding that delayed biosimilar entries caused by brand-name biologic manufacturer patent accumulation or “thicketing” has cost the U.S. health care system $7.6B since 2015. This includes more than $1.2B in lost savings to the Medicare program.

  5. Prestige BioPharma Reports Positive Top-Line Phase III Results For Tuznue® (Trastuzumab Biosimilar)

    Prestige BioPharma (herein, Prestige) today announced positive top-line results from a Phase III global clinical trial (Troika) evaluating the efficacy, safety, and pharmacokinetics (PK) of biosimilar candidate HD201 to Herceptin (trastuzumab).

  6. Samsung Bioepis Announces EU Label Update For IMRALDI (Adalimumab), With Extended Storage Conditions

    Samsung Bioepis Co., Ltd. announced recently that the European Medicines Agency (EMA) has approved an update to the label of IMRALDI (adalimumab) to extend the maximum storage period at room temperature conditions (up to 25˚C) for up to 28 days.

  7. European Medicines Agency Accepted First ‘China-Developed’ Biosimilar - Henlius HLX02 Marketing Authorization Application For Review

    Henlius, a leading biotech company in China developing both biosimilar and innovative biologics, announced today that the European Medicines Agency (EMA) has officially accepted to review the Marketing Authorization Application (MAA) of its trastuzumab biosimilar HLX02.

  8. Health Experts Agree Increasing Biosimilar Use Can Help Reduce Rising Drug Costs For Patients

    Yesterday, notable health leaders spoke about the importance of increasing biosimilars to lower health care costs during a POLITICO panel event sponsored by the Biosimilars Forum. Panelists included Congresswoman Diana DeGette (D-CO), Health and Human Services (HHS) official John O’Brien, University of Pittsburgh Professor Inmaculada Hernández, an expert in pharmacy and therapeutics policy, and Leslie Ritter of the National MS Society.

  9. Vizient To Collaborate With Civica Rx To Help Improve Drug Availability And Affordability By Providing Analytic Data Into Provider Needs

    Vizient announces that it is collaborating with Civica Rx to help reduce the impact of drug shortages. By providing insights into purchasing patterns and provider needs through its industry-leading analytics and data capabilities, Vizient will help Civica anticipate gaps in drug availability and affordability.

  10. New Sandoz Biosimilar Adalimumab Data Confirms Switching From Reference Biologic Has No Impact On Safety Or Efficacy

    Sandoz, a Novartis division and a global leader in biosimilars, recently announced data from the Phase III ADMYRA trial demonstrating that the efficacy and safety of biosimilar Hyrimoz (adalimumab) matches that of the reference medicine adalimumab with no clinically meaningful differences in patients with moderate-to-severe rheumatoid arthritis (RA) with inadequate response to disease modifying antirheumatic drugs (DMARDs), including methotrexate (MTX).