Biosimilars | Specialty

OncLive’s November Roundup of Key FDA Approvals in Oncology: 10 Decisions to Know

December 2nd 2025

Here is your cheat sheet to all therapeutic options that were cleared by the FDA in November 2025 spanning tumor types.

FDA Approves Osvyrti and Jubereq in High Fracture Risk Populations, Including in Breast and Prostate Cancer

November 20th 2025

Denosumab-desu (Osvyrti and Jubereq) received FDA approval in the same indications as reference denosumab (Prolia and Xgeva).

FDA Approves New Pertuzumab Biosimilar for Select HER2+ Breast Cancer Subtypes

November 13th 2025

The FDA has approved pertuzumab-dpzb as the first interchangeable biosimilar for pertuzumab across several indications in HER2-positive breast cancer.

OncLive’s September Roundup of Key FDA Approvals in Oncology: 4 Decisions to Know

October 3rd 2025

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

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

September 30th 2025

The FDA approved Enoby and Xtrenbo, denosumab biosimilars referencing Prolia and Xgeva, respectively.

FDA Approves 2 Denosumab Biosimilars in High Fracture Risk Populations, Including in Breast and Prostate Cancer

September 17th 2025

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

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

September 2nd 2025

OncLive’s August Roundup of Key FDA Approvals in Oncology: 3 Decisions to Know

September 2nd 2025

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

The OncFive: Top Oncology Articles for the Week of 8/3

August 9th 2025

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

Denosumab Biosimilar Earns European Approval in Advanced Malignancies Involving the Bone and Giant Cell Tumors of the Bone

July 2nd 2025

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.

CHMP Shares Positive Opinion for Denosumab Biosimilars for Osteoporosis and Skeletal-Related Cancer Complications

June 3rd 2025

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

FDA Greenlights Bevacizumab Biosimilar in Multiple Solid Tumor Indications

April 10th 2025

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

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.