Specialty drugs, especially biologics, will constitute a significant portion of global drug spending by 2029, driven by cancer care costs. Autoimmune diseases and multiple sclerosis are key short-term ...

This analysis reviews the history and current status of biosimilar regulation in the US, concluding that changing the FDA’s interchangeability standards—as proposed by some policy makers—is a ...

The agency will no longer require studies comparing copycat biologics to their branded counterparts, which could help ...