Policy

BioRationality: Questioning Experts and Journals Reporting on Biosimilar Bill to Remove Interchangeability

June 23rd 2025

By Sarfaraz K. Niazi, PhD

The debate over the Biosimilar Red Tape Elimination Act raises critical concerns about FDA standards, physician trust, and patient safety in biosimilars.

FDA Approves Steqeyma for Children With Plaque Psoriasis, Psoriatic Arthritis

June 17th 2025

By Skylar Jeremias

Celltrion's FDA approval of Steqeyma enhances pediatric psoriasis treatment, offering flexible dosing options for children with chronic inflammatory conditions.

New Data Support Hulio as an Interchangeable Adalimumab Option

June 16th 2025

By Skylar Jeremias

The new data were collected to fulfill the FDA's requirements to designate adalimumab-fkjp (Hulio) as interchangeable with Humira, enhancing access to affordable biologics for chronic plaque psoriasis treatment.

BioRationality: The Urgency of Removing Clinical Efficacy Studies

June 2nd 2025

By Sarfaraz K. Niazi, PhD

Biosimilar associations advocate for lower development costs and streamlined regulations to enhance patient access to affordable biosimilars.

Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships

May 29th 2025

By Skylar Jeremias

The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.

British Columbia’s Biosimilar Policy Shows No Impact on Hospital Visits

May 28th 2025

By Skylar Jeremias

Despite a dramatic shift toward biosimilar use following British Columbia’s policy, researchers found no rise in hospital visits or complications, underscoring the real-world reliability of etanercept biosimilars in managing inflammatory arthritis.

FDA Approves Starjemza as New Stelara Biosimilar

May 27th 2025

By Skylar Jeremias

Starjemza gains FDA approval as the eighth ustekinumab biosimilar, enhancing treatment options for rheumatic and gastrointestinal conditions.

Biosimilars Can Help Expand Early Access Anti-TNF Therapy in IBD

May 26th 2025

By Deana Ferreri, PhD

There's a need for early anti-tumor necrosis factor (TNF) therapy in inflammatory bowel disease (IBD), with new data showing that biosimilars can address cost barriers and enhance patient access and outcomes.

What Stands in the Way of Biosimilar Use Across MENA Countries?

May 21st 2025

By Skylar Jeremias

Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.

BioRationality: The Revised Indian Biosimilar Guidelines Finally Bring Rationality

May 19th 2025

By Sarfaraz K. Niazi, PhD