The OncLive Biosimilars condition center page is a comprehensive resource for clinical news and expert insights on currently available and investigational biosimilars for reference drugs such as trastuzumab, rituximab, bevacizumab, and more. 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.
June 26th 2024
First-line cetuximab beta injection has received NMPA marketing approval in RAS/BRAF wild-type metastatic colorectal cancer.
Advances In™: Targeting PSMA to Advance Diagnosis And Management Of Patients With Prostate Cancer
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Community Practice Connections™: 14th Annual International Symposium on Ovarian Cancer and Other Gynecologic Malignancies
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Clinical Case Vignette Series: Integrating Recent Data into Practice to Improve Outcomes in Advanced Prostate Cancer
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Community Practice Connections™: The Advent of TROP2-Targeted Treatment Approaches in HR+/HER2- Breast Cancer
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Community Practice Connections™: 8th Annual School of Gastrointestinal Oncology®
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Show Me the Data™: Do We Have Sea Change for Novel Approaches in HR+/HER2- Breast Cancer? CDK, PI3K/AKT, ADC, and Next-Gen SERD Strategies Assessed
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B-Cell Tumor Board: Rendering Real World Personalized Treatment Plans in CLL/SLL and MCL Through the Lens of Emerging BTKi Evidence
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Community Practice Connections™: Controversies and Conversations About HER2- Expressing Breast Cancer…Advances in Management of HER2-Low to -Positive Disease
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Cancer Summaries and Commentaries™: Clinical Updates from Chicago in Breast Cancer
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7th Annual Live Medical Crossfire®: Hematologic Malignancies
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Cancer Summaries and Commentaries™: Clinical Updates in RCC from Chicago
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Community Practice Connections™: Integrating BTK Inhibitors Into the CLL/SLL and MCL Treatment Paradigm
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Community Practice Connections™: What the Community Needs to Know to Apply RLT in PSMA-Positive mCRPC in Context with Current Treatment Paradigms
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San Diego Lung Symposia
September 7, 2024 - September 8, 2024
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Pathology Implications for CEACAM5 as a Therapeutic Target in Advanced NSCLC
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2024 International Symposium of Gastrointestinal Oncology (ISGIO)
October 11-12, 2024
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Virtual Show Me the Data™: How HER2, HER3, and TROP2 Targeted Strategies Will Impact Evolving Paradigms in NSCLC
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Applying New Evidence in Multiple Myeloma Care from Frontline to R/R Disease
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Medical Crossfire®: How Does Recent Evidence on PARP Inhibitors and Combinations Inform Treatment Planning for Prostate Cancer Now and In the Future?
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Medical Crossfire®: How Do Clinicians Integrate the Latest Evidence in Treating Ovarian Cancer to Personalize Care?
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Community Practice Connections™: 5th Annual Precision Medicine Symposium – An Illustrated Tumor Board
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Community Practice Connections™: Optimize the Diagnosis and Treatment of HER2-Positive Colorectal Cancer
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How CEACAM5 Expression Can Be Measured and Leveraged in NSCLC Care: Current Developments & Future Therapeutic Opportunities
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Medical Crossfire®: Where Are We in the World of ADCs? From HER2 to CEACAM5, TROP2, HER3, CDH6, B7H3, c-MET and Beyond!
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Community Oncology Connections™: Overcoming Barriers to Testing, Trial Access, and Equitable Care in Cancer
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Translating New Evidence into Treatment Algorithms from Frontline to R/R Multiple Myeloma: How the Experts Think & Treat
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Medical Crossfire: How Has Iron Supplementation Altered Treatment Planning for Patients with Cancer-Related Anemia?
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Dialogues With the Surgeon on Integration of Systemic Therapies in Perioperative Settings for NSCLC: Looking at EGFR, ALK, IO, and Beyond…
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The Next Wave in Biliary Tract Cancers: Leveraging Immunogenicity to Optimize Patient Outcomes in an Evolving Treatment Landscape
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42nd Annual Miami Breast Cancer Conference®
March 6 - 9, 2025
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FDA Approves Delivery System of Biosimiliar Pegfilgrastim-cbqv for Febrile Neutropenia
The FDA has approved an on-body injector (OBI) presentation of the biosimilar pegfilgrastim-cbqv biosimilar (Udencya), known as Udencya Onbody, which is administered to patients with cancer the day after chemotherapy in order to decrease infection incidence from febrile neutropenia.
EG12014 Gets Go Ahead in EU for HER2+ Breast and Metastatic Gastric Cancers
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.
FDA Issues CRL to BLA for On-Body Injector Presentation of Pegfilgrastim-cbqv
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.
Trastuzumab Biosimilar Receives CHMP Recommendation for HER2+ Breast and Gastric Cancer
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.
Novel Program Provides Avenue for Increased Biosimilar Uptake, Reduced Cost
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.
FDA Accepts BLA for Trastuzumab Biosimilar in HER2+ Breast Cancer, Gastric/GEJ Cancer
April 5th 2023The 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
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.
FDA Approves Pegfilgrastim Biosimilar for Febrile Neutropenia
The FDA has approved the biosimilar pegfilgrastim for use in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.
Bevacizumab Biosimilar CT-P16 Approved in Europe for Multiple Cancer Types
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.
Sintilimab Combo Reduces Risk of Progression by 54% in EGFR-Mutated Nonsquamous NSCLC
The addition of sintilimab to a bevacizumab biosimilar and pemetrexed/cisplatin resulted in a statistically significant and clinically meaningful improvement in progression-free survival vs chemotherapy alone in patients with EGFR-mutated, nonsquamous non–small cell lung cancer who progressed after an EGFR TKI.
Novel Sintilimab Combo Significantly Improves PFS in EGFR-Mutated Nonsquamous NSCLC
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.
Knowledge of Biosimilars Becomes A Necessity in Oncology Nursing
August 9th 2021Understanding the functionality and naming convention of biosimilars vs their biologic counterparts are important concepts to utilizing these agents in oncology, according to a presentation given by Teresa Knoop, MSN, RN, AOCN, during the 5th Annual School of Nursing Oncology Meeting.
Biosimilars Gain Traction, Generate Savings
The use of oncology biosimilars has expanded rapidly in the United States during the past 2 years as providers embraced a growing armamentarium of new products, according to findings from real-world data reported at the 2021 American Society of Clinical Oncology Annual Meeting.
Rituximab Biosimilar CT-P10 Demonstrates Real-World Safety, Efficacy in DLBCL
The rituximab biosimilar CT-P10 produced response and survival rates that were comparable to those previously reported with the reference product, along with acceptable tolerability, in patients with diffuse large B-cell lymphoma.
Physician Confidence in Biosimilars Rests on Real-world Data
Providers and health care institutions want more real-world data on how patients respond to various biosimilar products, according to a varied panel of private practice, academic hospital, and group purchasing organization experts in a discussion at the Community Oncology Alliance virtual 2021 Community Oncology Conference in April.
FDA Approves Rituximab Biosimilar for NHL, CLL, GPA, and MPA
December 17, 2020 - The FDA has approved rituximab-arrx, a biosimilar to rituximab, for the treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.
Injectable Sintilimab/Bevacizumab Biosimilar Combo Improves Survival in Frontline HCC
Frontline sintilimab injection in combination with bevacizumab biosimilar injection resulted in a statistically significant improvement in progression-free survival and overall survival compared with sorafenib in patients with advanced hepatocellular carcinoma.