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Biosimilars

FDA Requests Additional Information for Pfizer’s Application for its Proposed Trastuzumab Biosimilar

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that it received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) in response to the Biologics License Application for the company’s proposed trastuzumab biosimilar. In the CRL, the FDA highlighted the need for additional technical information. The …

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Pfizer Announces Positive Top-Line Results for Potential Biosimilar to Rituxan/MabThera

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that REFLECTIONS B3281006, a comparative safety and efficacy study of PF-05280586 versus MabThera® (rituximab-EU), met its primary endpoint. PF-05280586 is being developed by Pfizer as a potential biosimilar to Rituxan® (rituximab-US)/MabThera®1. The trial demonstrated equivalence in overall response rate (ORR) for the first-line treatment of …

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Sandoz Announces Exclusive Global Collaboration with Biocon on Next-Generation Biosimilars

Holzkirchen, 18 January 2018 – Sandoz, a Novartis division and the global leader in biosimilars, today announced a global partnership with Asia’s premier biopharmaceuticals company, Biocon, to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide. Under the terms of the agreement, both companies will share responsibility …

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Mylan and Momenta Announce Development Strategy for Proposed Biosimilar to Eylea

CAMBRIDGE, Mass. and HERTFORDSHIRE, England and PITTSBURGH, Jan. 3, 2018 /PRNewswire/ — Momenta Pharmaceuticals, Inc. (Nasdaq: MNTA) and Mylan N.V. (NASDAQ, TASE: MYL) today announced the development strategy for M710, a proposed biosimilar to EYLEA® (aflibercept) injection. EYLEA is the market-leading vascular endothelial growth factor (VEGF) inhibitor indicated for the …

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FDA Accepts for Review Samsung Bioepis’ SB3 Trastuzumab Biosimilar Candidate

INCHEON, Korea–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) under the 351(k) pathway for SB3, a biosimilar candidate referencing Herceptin® i (trastuzumab). SB3 is Samsung Bioepis’ first oncology biosimilar candidate submitted for regulatory review …

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FDA Approves Pfizer’s Ixifi, a Biosimilar to Remicade

Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved IXIFI™ (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product.1 The FDA has approved IXIFI as …

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FDA Approves Sanofi’s Admelog, a Biosimilar of Humalog

PARIS, Dec. 11, 2017 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved Sanofi’s Admelog®, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime. “Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes. Complementing our existing insulin …

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New Phase 1 Data Shows Sandoz’s Proposed Biosimilar Pegfilgrastim Matches Reference Medicine

HOLZKIRCHEN, Germany, Dec. 8, 2017 /PRNewswire/ — Sandoz, a division of Novartis and the global leader in biosimilars, today announced data demonstrating the pharmacokinetics (PK), pharmacodynamics (PD), safety and immunogenicity of proposed biosimilar pegfilgrastim as compared to the reference biologic, Neulasta®*1. The Phase I study, conducted in healthy volunteers, confirmed …

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FDA Approves Ogivri, the First Biosimilar for Treatment of Certain Breast and Stomach Cancers

HERTFORDSHIRE, England, PITTSBURGH and BENGALURU, India, Dec. 1, 2017 /PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab), co-developed with Biocon. Ogivri has been approved for all indications included in the label of …

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One Year Maintenance and Switching Data in Patients with Crohn’s Disease Support the Use of Inflectra in IBD

NEW YORK–(BUSINESS WIRE)–New data show that switching patients with Crohn’s disease (CD) to INFLECTRA (infliximab CT-P13) from REMICADE (infliximab) led to comparable efficacy, safety and tolerability to treatment with REMICADE over a 24 week period.1The full 54-week results of the randomized controlled trial comparing INFLECTRA and REMICADE in biologic-naïve patients …

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