Biosimilars | Specialty

The biosimilars condition center is a comprehensive resource for clinical news and expert insights on biosimilars. Read more at 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.

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.