Biosimilars

Two denosumab biosimilars received approval from the FDA for the purpose of increasing bone mass in individuals at high risk for fracture.

Here is your guide to all therapeutic options that were cleared by the FDA in August 2025 spanning tumor types.

The FDA grants accelerated approval to zongertinib in lung cancer, clears dordaviprone in glioma, and awards priority review to liso-cel sBLA in MZL.

Denbrayce was approved in Europe for the treatment of skeletal-related events in advanced malignancies involving the bone and giant cell tumor of the bone.

The European Medicines Agency's CHMP has recommended the use of denosumab biosimilars referencing Prolia and Xgeva in all reference product indications.

The bevacizumab biosimilar Jobevne was approved by the FDA for the treatment of several solid tumor types, including mCRC, NSCLC, and RCC.

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

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

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

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

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.

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

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

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

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

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

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

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, 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.

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.

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.

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.

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.

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