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.

OncLive’s FDA Approval Report: The Regulatory Rundown for March 2025

April 2nd 2025

Here is your snapshot for all therapeutic options that were approved by the FDA in March 2025 spanning tumor types.

Denosumab Biosimilars Earn Positive CHMP Opinion for Osteoporosis and Cancer-Related Bone Disease

April 2nd 2025

The EMA’s CHMP has issued a positive opinion for the denosumab biosimilars Osvyrti and Jubereq for the same indications as the reference products.

FDA Approves 2 Denosumab Biosimilars for Osteoporosis and Cancer-Related Bone Disease

March 4th 2025

The FDA has approved 2 denosumab biosimilars for all indications of their respective reference medications.

The OncFive: Top Oncology Articles for the Week of 2/2

February 8th 2025

Encorafenib combination boosts survival in BRAF V600E+ mCRC, pertuzumab biosimilar BLA is under review for HER2+ breast cancer, and more from OncLive.

Neoadjuvant Pertuzumab Biosimilar Plus Trastuzumab/Docetaxel Meets pCR End Point in HER2+ Breast Cancer

October 7th 2024

HLX11—a pertuzumab biosimilar—plus trastuzumab/docetaxel met the pCR end point in a phase 3 trial in early or locally advanced HER2-positive breast cancer.

Bevacizumab Biosimilar Receives Approval in the European Union

July 30th 2024

The European Medicines Agency has approved Avzivi, a biosimilar referencing bevacizumab.

Cetuximab Biosimilar Receives NMPA Approval For RAS/BRAF Wild-Type CRC

June 26th 2024

First-line cetuximab beta injection has received NMPA marketing approval in RAS/BRAF wild-type metastatic colorectal cancer.

Bevacizumab Biosimilar Avzivi Receives Positive CHMP Opinion

June 3rd 2024

The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion for Avzivi, a monoclonal antibody referencing bevacizumab.

EMA Validates Filings for Denosumab Biosimilar Candidate HLX14 for Osteoporosis

May 24th 2024

Marketing authorization applications for the denosumab biosimilar HLX14 have been validated by the EMA.

European Commission Approves Two Denosumab Biosimilars

May 22nd 2024

Two biosimilars for reference denosumab have received marketing authorization from the European Commission.

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.