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.
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 ...
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 ...
Medicare Price Negotiations Will Slow Biosimilar Momentum, Widening Market Gap ...
Medicare Price Negotiations Will Slow Biosimilar Momentum, Widening Market Gap ...
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 ...
Reforming patent litigation to mirror successful outcomes across Europe could significantly accelerate US biosimilar market entry. The biosimilar market could be accelerated through patent litigation ...
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