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Biosimilars

FDA Accepts Samsung Bioepis’ BLA for SB8 Bevacizumab Biosimilar Candidate

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB8, a biosimilar candidate referencing AVASTIN®i (bevacizumab). The BLA for SB8 was submitted by Samsung Bioepis in September 2019. If …

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FDA Approves Pfizer’s Biosimilar Abrilada (adalimumab-afzb) for Multiple Inflammatory Conditions

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab),1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.2 For full details …

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Sandoz Receives FDA Approval for Long-Acting Oncology Supportive Care Biosimilar Ziextenzo (pegfilgrastim-bmez)

Holzkirchen, Nov. 5, 2019 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its biosimilar ZiextenzoTM (pegfilgrastim-bmez). Sandoz biosimilar pegfilgrastim has been approved and marketed in Europe as Ziextenzo® (pegfilgrastim) since 2018.  Sandoz now intends to launch Ziextenzo in the …

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[Fam-] Trastuzumab Deruxtecan Granted FDA Priority Review for Treatment of HER2-positive Metastatic Breast Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) today announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) date for [fam-] trastuzumab deruxtecan, …

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Sandoz Announces Global Deal to Commercialize Proposed Biosimilar Natalizumab

Holzkirchen, Germany, September 3, 2019 – Sandoz, a Novartis division and a global leader in biosimilars, today announced that it has entered into a global commercialization agreement for a proposed natalizumab biosimilar. The medicine is in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS). Under the agreement, …

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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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