New research reveals that switching from originator to biosimilar adalimumab for hidradenitis suppurativa may lead to reduced ...

FDA approves Poherdy, the first interchangeable biosimilar for Perjeta, enhancing competition in HER2-positive breast cancer ...

The Center for Biosimilars connects professionals with insights on biosimilars, health economics, regulatory outcomes, and ...

FDA approves multiple denosumab biosimilars, enhancing market access and introducing interchangeability, boosting competition in bone health therapies.

A recent study confirms the stability of XSB-001 biosimilar for retinal diseases under realistic clinical handling conditions. Ranibizumab, an anti–vascular endothelial growth factor (VEGF)–A fragment ...

A new biosimilar for aflibercept shows similar efficacy and safety in treating neovascular age-related macular degeneration (nAMD), enhancing patient access to treatment. A biosimilar to aflibercept ...

While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more ...

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 ...

Since the FDA’s groundbreaking approval of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption ...

The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.

Functional similarity of the ustekinumab biosimilar ABP 654 (Wezlana) and the reference product (Stelara) was confirmed by a series of in vitro studies, which support the totality of evidence for the ...