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 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.

Knowledge of Biosimilars Becomes A Necessity in Oncology Nursing

August 9th 2021

Understanding 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

July 26th 2021

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

June 14th 2021

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.

FDA Accepts Application for Lupin Limited’s Pegfilgrastim Biosimilar

June 4th 2021

The FDA has accepted the biologics license application for a proposed biosimilar for pegfilgrastim, which had been developed by Lupin Limited.

Oncology Biosimilar Market Is Growing

May 20th 2021

Although the United States is behind Europe in terms of biosimilars approved and launched, the FDA is adding more approvals each year—29 since 2014—and 73 additional biosimilar candidates are in clinical trials and/or under FDA review.

Physician Confidence in Biosimilars Rests on Real-world Data

May 19th 2021

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.

Adoption of Biosimilars Varies by Practice Setting

March 29th 2021

The use of biosimilars to treat patients may differ across drug classes, according to a new study examining the relationship between biosimilar use and practice setting and patient/physician characteristics.

FDA Approval Sought for Bevacizumab Biosimilar BAT1706

January 29th 2021

January 28, 2021 - The FDA has accepted a biologics license application for BAT1706, a proposed biosimilar to bevacizumab.

FDA Defers Action on BLA for Bevacizumab Biosimilar MYL-1402O

January 6th 2021

January 6, 2020 - The FDA has deferred action on the biologics license application for the proposed bevacizumab biosimilar MYL-1402O.