Biosimilar, FDA

FDA OKs First Rapid-Acting Insulin Biosimilar for Diabetes
The FDA approved insulin-aspart-szjj (Merilog) as the first rapid-acting insulin biosimilar product to treat adults and children with diabetes, the agency announced Friday. Like i
FDA approves Sanofi biosimilar product for treatment of diabetes
The U.S. Food and Drug Administration approved Merilog as biosimilar to Novolog for the improvement of glycemic control in adults and pediatric
FDA Approves Third Tocilizumab Biosimilar
The biosimilar will be available in both subcutaneous and intravenous formulations and has nearly all the same indications as the originator tocilizumab, Actemra.
FDA gives nod to first rapid-acting insulin biosimilar for diabetes treatment
The U.S. Food and Drug Administration (USFDA) on Friday approved Merilog as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus.
FDA Approves Tocilizumab Biosimilar Avtozma
The FDA has approved Avtozma® (tocilizumab-anoh), a biosimilar to Actemra®, in both intravenous and subcutaneous formulations.
Sanofi gets FDA approval for NovoLog insulin biosimilar
Sanofi (NASDAQ:SNY) has received FDA approval for Merilog, a biosimilar of Novo Nordisk's (NVO) rapid-acting insulin product NovoLog, for the improvement of glycemic control in adults and children with diabetes mellitus.
Business Wire4h
FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to Prolia and Xgeva
Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OS ...
FiercePharma10d
With recent launches and more to come, Amgen's biosimilar business is trending up
After recent launches of biosimilar versions of Eylea and Stelara, Amgen projects its biosimilar sales will reach $4 billion ...
Medscape12d
How to Reduce Nocebo Concerns in Biosimilar Use
A new study outlined 13 key strategies to counter the nocebo effect, ensuring smoother biosimilar transitions and better ...
Business Wire4h
Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (OBODENCE™, XBRYK™)
Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCE™ (60mg pre-filled syringe ...
Contract Pharma1d
UniSafe Device Drives Biosimilar Success in Japan
The success of NIPRO’s biosimilar product, launched in late 2023, has exceeded expectations and gained significant market ...