Biosimilars | Specialty

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.

FDA Approves Trastuzumab-strf for HER2-Overexpressing Breast and Gastric/GEJ Cancer

April 29th 2024

The FDA has approved trastuzumab-strf for HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or GEJ adenocarcinoma.

FDA Approves Delivery System of Biosimiliar Pegfilgrastim-cbqv for Febrile Neutropenia

December 26th 2023

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

November 28th 2023

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.

BLA Resubmitted to FDA for On-Body Injector Presentation of Pegfilgrastim-cbqv

October 5th 2023

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.

FDA Issues CRL to BLA for On-Body Injector Presentation of Pegfilgrastim-cbqv

September 25th 2023

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

September 18th 2023

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

July 27th 2023

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 2023

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

FDA Approves Biosimilar Pegfilgrastim-cbqv for Febrile Neutropenia

March 6th 2023

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 Accepts BLA for Denosumab Biosimilar for Reference Product Indications

February 6th 2023

The FDA has accepted for review a biologics license application for a proposed denosumab biosimilar, according to an announcement from Sandoz, Inc.

The State of Biosimilars: Obstacles and Barriers to Use in 2022

December 7th 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.

FDA Approves Bevacizumab-adcd Biosimilar in Six Solid Tumors

September 28th 2022

The FDA has approved bevacizumab-adcd, a bevacizumab biosimilar, for the treatment of six types of cancer.

FDA Approves Pegfilgrastim Biosimilar for Febrile Neutropenia

September 6th 2022

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

August 19th 2022

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.

TX05 Provides Comparable DFS Benefit to Trastuzumab in Early-Stage HER2+ Breast Cancer

June 27th 2022

Adjuvant treatment with TX05 resulted in a similar disease-free survival benefit to that of trastuzumab in patients with early-stage HER2-positive breast cancer.

FDA Approves Third Pegfilgrastim Biosimilar for Neutropenia

May 31st 2022

The FDA has approved the biologics license application for pegfilgrastim-pbbk, a biosimilar referencing Neulasta for the treatment of neutropenia.

FDA Approves Third Bevacizumab Biosimilar

April 18th 2022

The FDA has approved the third biosimilar for bevacizumab: bevacizumab-maly (Alymsys).

Sintilimab Combo Reduces Risk of Progression by 54% in EGFR-Mutated Nonsquamous NSCLC

November 22nd 2021

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

October 18th 2021

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.

Overcoming Hurdles to Biosimilar Uptake

September 6th 2021

Sanjiv S. Agarwala, MD, explains that biologics have revolutionized the treatment of serious conditions, including cancer, over the past few decades, however, costs are a pressing issue for all providers and biologics are a major culprit.