Biosimilars

FDA Accepts for Review Mylan and Biocon’s BLA for Proposed Biosimilar Bevacizumab

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, March 9, 2020 /PRNewswire/ — Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has accepted Mylan’s Biologics License Application (BLA) for MYL-1402O, a proposed biosimilar to Avastin® (bevacizumab), for review under the 351(k) pathway. The BLA seeks approval …

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Merck to Focus on Key Growth Pillars Through Spinoff of Women’s Health, Trusted Legacy Brands and Biosimilars Products into New Company (“NewCo”)

KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced its intention to spin-off products from its Women’s Health, trusted Legacy Brands, and Biosimilars businesses into a new, yet-to-be-named, independent, publicly traded company. The spinoff will allow both management teams to drive increased responsiveness …

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Amgen and Allergan Submit BLA to the FDA for ABP 798, a Biosimilar Candidate to Rituxan

THOUSAND OAKS, Calif., Dec. 19, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 798, a biosimilar candidate to Rituxan® (rituximab). Amgen and Allergan are collaborating on four oncology biosimilar medicines, two of which have already been approved by the FDA. “The U.S. filing …

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FDA Approves Amgen’s Avsola (infliximab-axxq), for the Same Indications as Remicade

THOUSAND OAKS, Calif., Dec. 6, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AVSOLA™ (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn’s Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis (UC) in …

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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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