All News

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 Denosumab Shows Cost-Effectiveness Over Bisphosphonates in PMO

August 4th 2026

By Skylar Jeremias

Article

Biosimilar denosumab cleared a $150,000 per QALY cost-effectiveness threshold against bisphosphonates for high-risk PMO, but not always at $100,000.

Denosumab Biosimilar KN012 Matches Reference Drug in Phase 3 Osteoporosis Trial

July 30th 2026

By Pearl Steinzor

Article

KN012 achieved BMD equivalence with US-approved denosumab in postmenopausal women in China.

Eculizumab Biosimilar Shows Durable Benefit in Long-Term aHUS

July 29th 2026

By Pearl Steinzor

Article

A 50-patient study found sustained platelet recovery and low thrombotic microangiopathy rates through 52 weeks of biosimilar therapy, with favorable safety.

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.

Aflibercept Biosimilar SB15 Shows Real-World Efficacy Across Retinal Diseases

July 22nd 2026

By Pearl Steinzor

Article

Aflibercept biosimilar SB15 improved retinal anatomy while preserving vision in both treatment-naïve and switching patients with nAMD, RVO, and DME.

Biosimilar Ranibizumab Performs on Par With Innovator Drug Across Retinal Diseases

July 21st 2026

By Pearl Steinzor

Article

Nearly 5000 eyes and nearly 21,000 injections show comparable vision, anatomical, and safety outcomes between biosimilar ranibizumab and the innovator drug.

Real-World Natalizumab Biosimilar Switch Reduced Treatment Satisfaction Despite Stable Outcomes

July 20th 2026

By Brooke McCormick

Article

Real-world natalizumab biosimilar switching preserved relapsing-remitting MS outcomes but lowered treatment satisfaction, likely due to a nocebo effect.

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.