Discover the top 5 regulatory biosimilar news of 2025, highlighting FDA approvals that enhance treatment options and ...

FDA's new guidance clarifies promotional practices for biosimilars, ensuring accurate marketing and preventing misleading ...

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

Tyruko, the first natalizumab biosimilar for multiple sclerosis, promises significant savings and competition in the US market.

Biosimilar developers achieve key European approvals for denosumab and golimumab, enhancing patient access while facing US market entry delays.

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and ...

After much anticipation, the FDA approves the first interchangeable biosimilar, which is hoped to bring down the high cost of insulin. The FDA has approved Biocon Biologic's Semglee insulin glargine ...

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 ...

In the second setback this year for etanercept biosimilars, the US District Court for the District of New Jersey has ordered Samsung Bioepis to delay marketing Eticovo until 2029. Samsung Bioepis will ...

The FDA approved Celltrion USA’s Zymfentra (infliximab-dyyb), the world’s first and only subcutaneous infliximab product. Zymfentra is approved as a novel drug, and its development is based on ...