Regulatory

April 22nd 2025

Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.

April 21st 2025

Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.

April 16th 2025

To help bring down sky-high drug prices, President Donald Trump signed an executive order pushing for faster biosimilar development, more transparency, and tougher rules on pharmacy benefit managers—aiming to save billions and make meds more affordable for everyone.

April 15th 2025

States with fewer restrictions on biosimilar substitution tend to see higher uptake of interchangeable insulin glargine, showing how even small policy details can significantly influence biosimilar adoption and expand access to more affordable insulin.