Poll: Identify the Main Cause for Reverse Switching

The FDA approved Celltrion's Steqeyma (ustekinumab-stba), making it the seventh biosimilar slated to compete against blockbuster Stelara (reference ustekinumab) in 2025.

On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.

A recent study showed similar safety and efficacy of a bevacizumab biosimilar compared with the reference product (Avastin) in patients with metastatic colorectal cancer (CRC).

On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.

Sandoz's biosimilar denosumab (Jubbonti/Wyost) has demonstrated analytical, pharmacokinetic, pharmacodynamic, and clinical equivalence to reference denosumab (Prolia/Xgeva), supporting its approval and extrapolation to all approved indications.

The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.