Danish Registry Analysis Finds Consistent Safety After Switching to Infliximab Biosimilar GP1111

February 03, 2026

New Danish registry data confirm the safety of switching to infliximab biosimilars, showing low rates of serious adverse events in patients with inflammatory arthritis.

Q&A With Chelsee Jensen, PharmD: FDA Policy Shifts, Biosimilar Development Hurdles, and Market Access in 2026

February 02, 2026

Early Evidence Supports KM118 as a Biosimilar to Reference Pertuzumab

January 28, 2026

Milestone Approvals, Evolving PBM Models May Redefine the 2026 Biosimilar Landscape

January 27, 2026

FDA Draft Guidance on Biosimilars Is a Win for Patients; Now Congress Must Finish the Job

January 26, 2026

Promising Results for Ustekinumab, Adalimumab Biosimilars Presented at AAD

March 18th 2025

By Skylar Jeremias

Article

Biocon’s ustekinumab biosimilar matched reference ustekinumab in efficacy and safety, while an adalimumab biosimilar proved interchangeable with reference adalimumab, according to posters at the American Academy of Dermatology (AAD) annual meeting.

Review Calls for Path to Global Harmonization of Biosimilar Development Regulations

March 17th 2025

By Skylar Jeremias

Article

Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.

Retina Specialists’ Evolving View on Biosimilars in AMD Treatment

March 16th 2025

By Skylar Jeremias

Article

The introduction of biosimilars in the treatment of age-related macular degeneration (AMD) is raising concerns among physicians about cost-driven mandates and the autonomy to choose the best therapies for their patients, according to Paul Hahn, MD, PhD, FASRS, a retina specialist at NJ Retina.

Comparable Pregnancy and Infant Milestones With Infliximab Biosimilars vs Originator in IBD

March 15th 2025

By Deana Ferreri, PhD

Article

A study evaluating pregnancy outcomes and infant developmental milestones found similar outcomes between pregnant women with inflammatory bowel disease (IBD) who received reference infliximab and those who received a biosimilar.

The Top 5 Biosimilar Articles for the Week of March 10

March 14th 2025

By Cameron Santoro

Video

Here are the top 5 biosimilar articles for the week of March 10, 2025.

More Ustekinumab Biosimilars Join US Market Share Fight

March 13th 2025

By Skylar Jeremias

Article

Celltrion and Formycon with Fresenius Kabi launched their respective ustekinumab biosimilars (Steqeyma and Otulfi), joining 4 others that launched earlier this year.

Updates on the Use of Biosimilars for Pediatric Patients With Rheumatic Disease

March 12th 2025

By Sabina Alikhanov Palmieri, PharmD

Article

Although more research is needed in pediatric patients, biosimilars could improve treatment access and reduce costs.

Biosimilar Cases to Watch: Prolia/Xgeva and Denosumab Competitors

March 11th 2025

By Ha Kung Wong, JD

Article

The denosumab biosimilar market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.

BioRationality: FDA Needs More Time Before Working With USP on Biosimilars Development

March 10th 2025

By Sarfaraz K. Niazi, PhD

Article

Sarfaraz Niazi, PhD, urges the FDA to let the USPharmacopeia (USP) create product release specifications for biosimilars to cut costs, speed development, and enhance accessibility.

How AI Can Help Address Cost-Related Nonadherence to Biologic, Biosimilar Treatment

March 9th 2025

By Skylar Jeremias

Podcast

Despite saving billions, biosimilars still account for only a small share of the biologics market—what's standing in the way of broader adoption and how can artificial intelligence (AI) help change that?