"Not So Different": The Year in US Regulatory Activity for Biosimilars

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

To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."

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.

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?

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.

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.