Trastuzumab Biosimilar Receives CHMP Recommendation for HER2+ Breast and Gastric Cancer
OncLive » Biosimilars
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3d ago
The European Medicines Agency’s Committee for Medicinal Products for Human Use has issued a positive opinion recommending marketing authorization of EirGenix’s biosimilar for trastuzumab for the treatment of patients with HER2-positive breast and metastatic gastric cancers ..read more
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Novel Program Provides Avenue for Increased Biosimilar Uptake, Reduced Cost
OncLive » Biosimilars
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4M ago
The implementation of a pharmacist-driven biosimilar substitution program across American Oncology Network institutions resulted in increased uptake of biosimilar agents as well as financial savings for payers, patients, and providers ..read more
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FDA Accepts BLA for Trastuzumab Biosimilar in HER2+ Breast Cancer, Gastric/GEJ Cancer
OncLive » Biosimilars
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5M ago
The FDA has accepted a biologics license application for the HLX02, a proposed trastuzumab biosimilar, as adjuvant therapy for patients with HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma ..read more
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FDA Approves Biosimilar Pegfilgrastim-cbqv for Febrile Neutropenia
OncLive » Biosimilars
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7M ago
FDA Approves Biosimilar Pegfilgrastim-cbqv for Febrile Neutropenia The FDA has approved a single-dose, prefilled autoinjector presentation of pegfilgrastim-cbqv (Udenyca), which is a biosimilar of pegfilgrastim that is given the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia ..read more
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The State of Biosimilars: Obstacles and Barriers to Use in 2022
OncLive » Biosimilars
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7M ago
The State of Biosimilars: Obstacles and Barriers to Use in 2022 With patents expiring on some of the revolutionary agents in cancer treatment, the emergence of biosimilars as a lower-cost option has seen exponential growth ..read more
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FDA Accepts BLA for Denosumab Biosimilar for Reference Product Indications
OncLive » Biosimilars
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7M ago
FDA Accepts BLA for Denosumab Biosimilar for Reference Product Indications The FDA has accepted for review a biologics license application for a proposed denosumab biosimilar, according to an announcement from Sandoz, Inc ..read more
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FDA Approves Bevacizumab-adcd Biosimilar in Six Solid Tumors
OncLive » Biosimilars
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9M ago
The FDA has approved bevacizumab-adcd, a bevacizumab biosimilar, for the treatment of six types of cancer ..read more
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Novel Sintilimab Combo Significantly Improves PFS in EGFR-Mutated Nonsquamous NSCLC
OncLive » Biosimilars
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1y ago
The combination of sintilimab, a bevacizumab biosimilar injection, and chemotherapy resulted in a significant improvement in progression-free survival in patients with EGFR-mutated, nonsquamous, non–small cell lung cancer that as progressed following treatment with an EGFR TKI, meeting the primary end point of the phase 3 ORIENT-31 trial ..read more
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FDA Approves Third Pegfilgrastim Biosimilar for Neutropenia
OncLive » Biosimilars
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1y ago
The FDA has approved the biologics license application for pegfilgrastim-pbbk, a biosimilar referencing Neulasta for the treatment of neutropenia ..read more
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Bevacizumab Biosimilar CT-P16 Approved in Europe for Multiple Cancer Types
OncLive » Biosimilars
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1y ago
The European Commission has approved the bevacizumab biosimilar, CT-P16, for the treatment of patients with metastatic breast cancer, non–small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer, and cervical cancer ..read more
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