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© 2026 MJH Life Sciences™ and The Center for Biosimilars - Biosimilars, Health Economics & Insights. All rights reserved.

Abbreviated Biologics Pathway Could Revive Biosimilar Competition

August 19, 2026

An editorial modeled on Hatch-Waxman proposes an abbreviated FDA pathway granting biosimilars class-level interchangeability to spur competition.

Rituximab Biosimilars Show Comparable 6-Month Outcomes in AAV

August 14, 2026

Adalimumab Biosimilar Sustains Efficacy After Switch in Saudi Cohort

August 11, 2026

Analytical Characterization Supports Confidence in Monoclonal Antibody Biosimilars

August 06, 2026

Biosimilar Denosumab Shows Cost-Effectiveness Over Bisphosphonates in PMO

August 04, 2026

Featured Content

Biosimilars Round Up: July 2026

August 4th 2026

By Sabrina McCrear

Article

Congress advances biosimilar bills as new data emerge on romosozumab, tirzepatide, and ustekinumab biosimilar development.

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.

India's Anti-VEGF Biosimilars Cut Costs, Expand Access

July 30th 2026

By Brooke McCormick

Article

Anti-VEGF biosimilars in India matched reference therapy, lowered costs, and improved treatment access and adherence for retinal diseases.

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.