Explore the latest advancements in denosumab biosimilars, enhancing treatment options for osteoporosis and bone metastases in ...

Biosimilar development costs could plummet from $100 million to $5 million, enabling smaller companies to enter the market ...

In 2025, the latest biosimilar policy developments included bipartisan efforts to enhance affordability and reduce barriers ...

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

April E. Weisbruch is a partner at McDermott, Will, & Emery LLP. She focuses her practice on intellectual property (IP) matters, particularly in managing large-scale IP litigation and counseling. She ...

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 ...

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 ...

Product differentiation by concentration is a threat to the multiple adalimumab biosimilars approved but not yet launched. Multiple biosimilar developers have obtained FDA approval for biosimilar ...

Sarfaraz K. Niazi, PhD, discusses the regulatory approval of future messenger RNA (mRNA) vaccines, which will likely face fewer patent issues and are easy to replicate. The COVID-19 pandemic has ...