News

A Japanese study found high remission and continuation rates, plus non-inferior trough levels, after patients with IBD were switched to the infliximab biosimilar CT-P13.

Sandoz's Edward Li explains how biosimilar denosumab pricing could reshape cost-effectiveness, payer access, and gaps in osteoporosis care.

Bevacizumab-to-biosimilar-to-branded transitions delayed nAMD care and cost more than direct switches.

A study found no direct trial evidence for natalizumab or its biosimilar in MS and found limited cost-effectiveness vs most alternatives.

Most pediatric and young adult patients with IBD maintained stable disease activity and laboratory markers after switching from the adalimumab originator.

Rituximab biosimilars showed no significant 6-month differences vs the originator in antineutrophil cytoplasmic antibody–associated vasculitis (AAV).

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

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

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

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

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

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

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

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

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

Biosimilar anti-VEGF agents matched the reference ranibizumab in vision outcomes and safety across retinal diseases in India, at a lower cost.

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

Trial data show switching between ABP 654 and reference ustekinumab maintains similar psoriasis control, safety, and immunogenicity, supporting FDA interchangeability confidence.

Phase 3 data show denosumab biosimilar KN012 matches Prolia for BMD gains and safety, potentially expanding affordable osteoporosis care.

FDA expands Tofidence uses, Teva launches Eylea biosimilar in Europe, and Alvotech’s Entyvio rival enters FDA review—boosting access.

Early use of ustekinumab biosimilars in Spain shows cost-effective Crohn disease care, boosting QALYs and cutting NHS spend—insights for Europe.

Global review reveals uneven biosimilar rules on waivers, interchangeability, and safety tracking—barriers to cheaper biologics and approvals.

Italian study finds most MS patients start biosimilars unaware, exposing education gaps and highlighting MS nurses as key to boosting trust and uptake.

New EULAR guidelines speed RA treatment switches as rheumatoid arthritis biosimilars and cost savings push earlier biologics use.

The FDA has approved ranibizumab-hkdz (Ranluspec; Lupin Limited) as an interchangeable biosimilar for wet AMD, DME, DR, RVO, and mCNV.

Evidence shows biosimilars switching in ankylosing spondylitis maintains disease control with biologics, cuts costs, and highlights nocebo risks.

Immgolis and Immgolis Intri have the same indications as Simponi and Simponi Aria, treating patients with rheumatoid arthritis and ulcerative colitis. The biosimilars will be available in the fourth quarter of this year.

Evidence suggests that adoption of oncology biosimilars in Medicare value-based payment models has produced substantial cost savings and improved provider financial performance.

FDA approval clears interchangeable golimumab biosimilars for rheumatoid arthritis and ulcerative colitis, promising lower-cost TNF therapy.