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Biosimilars

Amgen and Allergan Announce Positive Top-Line Results from Comparative Clinical Study of ABP 798, Biosimilar Candidate to Rituxan

THOUSAND OAKS, Calif., Aug. 22, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced positive top-line results from a comparative clinical study evaluating the efficacy and safety of ABP 798, a biosimilar candidate to Rituxan® (rituximab), compared to Rituxan in patients with CD20-positive B-cell non-Hodgkin’s lymphoma. The primary endpoint, an assessment of overall response rate (ORR) …

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Amgen Wins Enbrel US Patent Litigation, Delaying Sandoz’s Biosimilar Plan

THOUSAND OAKS, Calif., Aug. 9, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. District Court for the District of New Jersey has ruled in Amgen’s favor on validity of the two patents that describe and claim Enbrel® (etanercept) and methods for making it. Amgen affiliates Immunex Corporation and Amgen Manufacturing, Limited, along with the owner and licensor of the two patents, Hoffmann-La …

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FDA Approves Samsung Bioepis’ Hadlima, a Biosimilar Referencing Humira

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® i (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis. Please see below the …

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FDA Approves Pfizer’s Biosimilar, Ruxience (rituximab-pvvr), for Certain Cancers and Autoimmune Conditions

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved RUXIENCE™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab),1 for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).2 “Biosimilars like RUXIENCE have …

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Amgen And Allergan’s MVASI (bevacizumab-awwb) and KANJINTI (trastuzumab-anns) Now Available in the United States

THOUSAND OAKS, Calif., July 18, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc(NYSE:AGN) today announced that MVASI™ (bevacizumab-awwb), a biosimilar to Avastin® (bevacizumab), and KANJINTITM (trastuzumab-anns), a biosimilar to Herceptin® (trastuzumab), are now available in the United States (U.S.). MVASI, the first oncology therapeutic biosimilar approved by the U.S. Food and Drug Administration (FDA), is approved for the treatment of five types of …

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FDA Approves Amgen and Allergan’s Kanjinti, a Biosimilar to Herceptin

THOUSAND OAKS, Calif., June 13, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. “The FDA approval of KANJINTI is …

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Statement from Acting FDA Commissioner Sharpless on Policy Advancements to Bring Interchangeable Biosimilars to Market

The U.S. Food and Drug Administration plays an important role in helping to address the high cost of medicines through the development of science-based policies that can improve competition and patient access to safe and effective, high-quality and lower cost generic drugs, biosimilars and interchangeable biologics. Today, the FDA is …

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Sandoz Enters Agreement with EirGenix for Proposed Trastuzumab Biosimilar in Phase 3 Development

Holzkirchen, Germany, April 30, 2018 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that it has entered into an agreement to commercialize a proposed trastuzumab biosimilar. This medicine is currently in Phase III clinical development for treatment of human epidermal growth factor receptor 2 positive (HER2+) …

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FDA Approves Samsung Bioepis’ Eticovo, a Biosimilar to Enbrel

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved ETICOVO™ (etanercept-ykro), a biosimilar referencing ENBREL® (etanercept), across all eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis. ETICOVO™ is Samsung Bioepis’ second …

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Data Published in The Lancet Shows that CT-P13 is Non-inferior to Reference Infliximab in Inflammatory Bowel Disease

LONDON–(BUSINESS WIRE)–Celltrion Healthcare announced today that The Lancet has published the full data-set from its randomised controlled trial (RCT) of CT-P13 (biosimilar infliximab) in Crohn’s disease (CD), the PLANETCD Study. Results from the phase III study demonstrated the non-inferiority of CT-P13 to reference infliximab in biologic-naïve patients with moderate-to-severe CD.1 CT-P13 is …

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