Biosimilars

Mylan and Fujifilm Kyowa Kirin Biologics Announce that the FDA Approved of Hulio, a Biosimilar to Humira

HERTFORDSHIRE, England and PITTSBURGH and TOKYO, July 9, 2020 /PRNewswire/ — Mylan N.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Hulio® (adalimumab-fkjp), a biosimilar to AbbVie’s Humira® (adalimumab), for the treatment of rheumatoid arthritis, juvenile idiopathic …

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FDA Approves Pfizer’s Oncology Supportive Care Biosimilar, NYVEPRIA (pegfilgrastim-apgf)

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved NYVEPRIA™ (pegfilgrastim-apgf), a biosimilar to Neulasta® (pegfilgrastim).1 NYVEPRIA is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a …

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Samsung Bioepis Announces Interim Results from Phase 3 Trial of SB11, Proposed Ranibizumab Biosimilar, in Neovascular Age-Related Macular Degeneration

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. announced today that the primary endpoints have been met in the randomized, double-masked, phase 3 trial comparing the efficacy, safety and immunogenicity of SB11, a ranibizumab biosimilar candidate, to reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD). “We are excited to share …

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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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