FDA, Biosimilar and Sanofi

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
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.
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 approves Celltrion's Avtozma, a biosimilar to Actemra
The US Food and Drug Administration (FDA) has approved Avtozma (CT-P47, tocilizumab-anoh) in both an intravenous (IV) and subcutaneous (SC) formulation as a biosimilar to Actemra, developed by South Korean firm Celltrion.
FDA Approves Tocilizumab Biosimilar Avtozma
The FDA has approved Avtozma® (tocilizumab-anoh), a biosimilar to Actemra®, in both intravenous and subcutaneous formulations.
FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
Agency Continues Efforts to Increase Access to Insulin Treatment Options SILVER SPRING, Md., /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Merilog (insulin-aspart-szjj) as biosimilar to Novolog (insulin aspart) for the improvement of glycemic control in adults and pediatric patients with diabetes mellitus.
FiercePharma9d
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 ...
JD Supra14h
Federal Circuit Affirms Finding Of Personal Jurisdiction And Preliminary Injunction Against Biosimilar Applicants
On January 29, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction by the Northern District of ...
Contract Pharma11h
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 ...