OncLive » Biosimilars
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This page features news articles, interviews in written and video format, and podcasts that focus on updates with biosimilars and ongoing research with these types of agents. OncLive is the official website for the Oncology Specialty Group, which publishes OncologyLive, Oncology Fellows, and Oncology Nursing News, and the mission of OncLive and these publications is to provide oncology..
OncLive » Biosimilars
1w ago
The biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, a biosimilar of pegfilgrastim, has been resubmitted to the FDA for review ..read more
OncLive » Biosimilars
1w ago
EG12014, a biosimilar of the anti-HER2 monoclonal antibody trastuzumab, has received a marketing authorization from the European Commission for use in the European Union for the treatment of patients with HER2-positive breast and metastatic gastric cancer; these are the same indications that trastuzumab holds in the EU ..read more
OncLive » Biosimilars
3w ago
The FDA has issued a complete response letter to the biologics license application seeking the approval of the on-body injector presentation of pegfilgrastim-cbqv, which is a biosimilar of pegfilgrastim ..read more
OncLive » Biosimilars
1M 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
OncLive » Biosimilars
6M 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
OncLive » Biosimilars
7M 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
OncLive » Biosimilars
9M 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
OncLive » Biosimilars
9M 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
OncLive » Biosimilars
9M 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
OncLive » Biosimilars
11M ago
The FDA has approved bevacizumab-adcd, a bevacizumab biosimilar, for the treatment of six types of cancer ..read more