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.

FDA's new guidance streamlines biosimilar development, reducing costs and regulatory hurdles and potentially enhancing market access and affordability. The FDA has issued draft guidance that ...

New research highlights the efficacy and high patient satisfaction of adalimumab biosimilars in treating inflammatory diseases. In response to the need for more real-world evidence on adalimumab ...

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 ...

Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, predict pharmacy benefit managers (PBMs) will evolve toward value-based care, mirroring the broader shift toward open-cost ...

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 ...