Development

Analytical Characterization Supports Confidence in Monoclonal Antibody Biosimilars

August 6th 2026

By Brooke McCormick

Analytical characterization supports monoclonal antibody biosimilar approvals and may reduce clinical testing needs, researchers found.

Biosimilar Bills Gain Steam in Congress, But Key Reforms Still Wait

July 23rd 2026

By Skylar Jeremias

Article

Congress fast-tracks biosimilar bills to cut drug and insulin costs, while patent, rebate, and reimbursement roadblocks still stall competition.

Romosozumab Biosimilar Matches Reference in Functional Testing Despite Disulfide Differences

July 16th 2026

By Brooke McCormick

Article

A romosozumab biosimilar showed comparable sclerostin binding and bone-signaling potency to the reference product despite disulfide isoform differences.

FDA Accepts Sandoz Generic Tirzepatide Applications Amid Biosimilar Development Gap

July 13th 2026

By Skylar Jeremias

Article

Sandoz moves toward US generic tirzepatide autoinjectors as FDA reviews ANDAs, signaling future GLP‑1 access amid patent and biosimilar gaps.

Rituximab Biosimilar Reached 75% Remission, Matched Innovator in Membranous Nephropathy

July 8th 2026

By Skylar Jeremias

Article

Real-world data shows rituximab biosimilars for membranous nephropathy match remission rates, cut costs, and expand treatment options.

Golimumab Biosimilar Matches Reference Drug in Year-Long RA Trial

March 19th 2026

By Skylar Jeremias

Article

One-year trial shows AVT05 golimumab biosimilar matches Simponi in rheumatoid arthritis, including switching, with comparable safety and immunogenicity outcomes.

Global Biosimilar Market Sees Structural Shifts, Regulatory Hurdles, and Pipeline Gains

March 10th 2026

By Skylar Jeremias

Article

Global biosimilar market shifts: Celltrion leads biosimilars in Asia, biosimilars in Europe expand, while Sandoz restructures and FDA hurdles loom.

FDA Issues Draft Guidance Aimed at Cutting Expenses for Biosimilar PK Studies

March 9th 2026

By Skylar Jeremias

Article

Biologics eat 51% of drug spending despite being 5% of prescriptions, but the FDA's new draft guidance hopes more competition can close that gap.

Biosimilar-Backed Triplet Regimen Shows Feasibility in Heavily Pretreated Liver Cancer

February 27th 2026

By Skylar Jeremias

Article

A phase 2 trial showed that combining targeted radiotherapy with PD-1 blockade and a bevacizumab biosimilar can elicit responses in advanced liver cancer.

Biosimilar Trastuzumab Emtansine Shows Consistent PFS in HER2-Positive Breast Cancer

February 20th 2026

By Skylar Jeremias

Article

Real-world India data show trastuzumab emtansine biosimilars deliver meaningful PFS and manageable safety in heavily pretreated HER2+ metastatic breast cancer.