Center for Biosimilars

Biosimilar CT-P43 Matches Ustekinumab in Treating Moderate to Severe Plaque Psoriasis

A phase 3 clinical trial found that the ustekinumab biosimilar CT-P43 demonstrated equivalent efficacy, safety, and ...
Center for Biosimilars

Gaps in Knowledge Persist Around Biosimilar Insulin Switching, Review Finds

Scoping review shows clinicians and patients still worry about biosimilar insulin switching, devices and safety—evidence gaps ...
Center for Biosimilars

Switching to Biosimilar Etanercept Shows No Impact on Efficacy, Safety Across 18 Trials

Real-world evidence shows switching between etanercept products and etanercept biosimilars preserves efficacy and safety, ...
Center for Biosimilars

Golimumab Biosimilar Matches Reference Drug in Year-Long RA Trial

One-year trial shows AVT05 golimumab biosimilar matches Simponi in rheumatoid arthritis, including switching, with comparable ...
Center for Biosimilars

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

Celltrion leads biosimilars in Asia, biosimilars in Europe expand, while Sandoz restructures and FDA hurdles loom.
centerforbiosimilars

James D. Chambers, PhD, MPharm, MSc

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market ...
centerforbiosimilars

Paul Cornes, BM, BCH, MA, MRCP, FRCR

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market ...
centerforbiosimilars

Saro Arakelians, PharmD

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market ...
centerforbiosimilars

Peter Pitts

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market ...
centerforbiosimilars

Skylar Jeremias

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market ...
centerforbiosimilars

FDA Approves Semglee Insulin Glargine as First Interchangeable Biosimilar

After much anticipation, the FDA approves the first interchangeable biosimilar, which is hoped to bring down the high cost of insulin. The FDA has approved Biocon Biologic's Semglee insulin glargine ...
centerforbiosimilars

Ahzantive Receives FDA Approval as New Eylea Biosimilar

The FDA has approved Ahzantive (aflibercept-mrbb) as the third biosimilar referencing Eylea (aflibercept) for the treatment of eye conditions, including age-related macular degeneration. Formycon and ...