Biosimilar Development News

  1. Pfenex Submits New Drug Application To U.S. FDA Seeking Approval Of PF708 For The Treatment Of Osteoporosis

    Pfenex Inc. recently announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of PF708 for the treatment of osteoporosis.

  2. Samsung Bioepis Announces Results Of Additional One-Year Follow-Up Study Comparing Event-Free Survival Of SB3 Trastuzumab Biosimilar Candidate To Reference Trastuzumab By ADCC Activity

    Samsung Bioepis Co., Ltd. recently announced the results of an additional one-year follow-up study comparing event-free survival (EFS) of SB3, a biosimilar candidate referencing HERCEPTIN 1 (trastuzumab), to reference trastuzumab (TRZ) by antibody-dependent cell-mediated cytotoxicity (ADCC) activity.

  3. Sandoz Biosimilar Zarxio (Filgrastim-Sndz) Reduced Out-Of-Pocket Costs For Medicare Patients With Breast Cancer Versus The Reference Medicine

    Sandoz, a Novartis division and the pioneer and global leader in biosimilars, presented findings from a real-world simulation model showing US Medicare cancer patients treated with biosimilar Zarxio (filgrastim-sndz) incurred less out-of-pocket (OOP) costs compared to those on reference filgrastim†. When researchers extrapolated the data to simulate one million claims (100,000 Medicare patients), Zarxio-related cost savings were projected to be approximately $9.6M.

  4. PHASE-XS – A New Proprietary Database Of Coherent Market Insights

    PHASE-XS is a database developed by Coherent Market Insights, a market intelligence and consulting company. This database provides clinical information about phase 3 and phase 4 products for biologics and biosimilars.

  5. Oncology Biosimilars Market To Become Worth US$17,478.2M By 2025 - TMR

    The TMR report finds that the global oncology biosimilars market would rise at a phenomenal 27.5% CAGR from 2017 and 2025. The report valued the market at US$2.1M in 2016. By 2025, it expects the market to pull in a value of US$17.47M.

  6. CVS Health Introduces New Approach To Pricing Of Pharmacy Benefit Management Services

    CVS Health (NYSE: CVS) today announced that it is introducing a new approach to the pricing of Pharmacy Benefit Management (PBM) services.

  7. Celltrion Healthcare Presents Positive Results For CT-P10, Biosimilar Rituximab, In Advanced Follicular Lymphoma At The American Society Of Hematology Meeting 2018

    Celltrion Healthcare recently presented new data at the American Society of Hematology Meeting (ASH) 2018, which shows that the efficacy and safety of CT-P10 is comparable to reference rituximab in patients with advanced follicular lymphoma (AFL) over two years.

  8. Pfizer Presents Positive 26-Week Data For PF-05280586, A Potential Biosimilar To Rituximab, At The American Society Of Hematology Annual Meeting

    Pfizer Inc. announced today at the American Society of Hematology Annual Meeting that the REFLECTIONS B328-06 study, a comparative safety and efficacy study of PF-05280586 versus Rituxan®/MabThera® (rituximab-EU)i, met its primary endpoint of overall response rate (ORR) at Week 26 of the 52-week study.

  9. Momenta Pharmaceuticals Provides Update on US Regulatory Strategy for M923, Proposed Biosimilar to HUMIRA

    Momenta Pharmaceuticals, Inc., a biotechnology company with a validated scientific platform focused on discovering and developing novel therapeutics to treat rare, immune-mediated diseases, today announced a revised regulatory strategy in the United States for M923, Momenta’s proposed biosimilar to HUMIRA.

  10. European Medicines Agency Accepts Extension Marketing Authorisation Application for Review of Celltrion's Remsima SC, the Subcutaneous Version of Remsima

    Celltrion, Inc. today announced that the European Medicines Agency (EMA) has accepted for review of the Extension Marketing Authorisation Application for ‘Remsima SC’, the subcutaneous (SC) version of Remsima®, the autoimmune disease therapeutic antibody biosimilar of infliximab.