February 17th 2025
The FDA approved Merilog (insulin-aspart-szjj) as the first biosimilar to reference Novolog (insulin aspart) for the treatment of adult and pediatric patients with type 2 diabetes.
February 14th 2025
November 27th 2024
A Look at the Regulatory Process for Approval of Biosimilar Insulins in Europe
July 29th 2017The emergence of biosimilar insulins may help broaden access to modern insulins, increase individualized treatment options, and reduce the cost of insulin therapy. Yet many healthcare providers may not understand the concept of biosimilarity and how biosimilar medications are similar, not identical, to their reference products.
Merck Wins Tentative FDA Approval of Follow-on Insulin Glargine
July 21st 2017The FDA has granted Merck’s insulin glargine (Lusduna Nexvue) tentative approval. Merck says that its follow-on basal insulin has met all required regulatory standards of clinical and nonclinical safety, efficacy, and quality for follow-on biologics.
Nevada Governor Signs Insulin Price Transparency Bill, Strictest in Nation
June 16th 2017Republican Nevada Governor Brian Sandoval yesterday signed into law the country’s strictest requirements for drug companies to show how they set prices for certain prescription drugs, with a specific focus on insulin.
Biosimilar Insulin Glargine Shows Pharmacokinetic and Pharmacodynamic Equivalence to the Originator
June 15th 2017The study pesented at the American Diabetes Association 77th Scientific Sessions compared Mylan/Biocon’s MYL-1501D, a proposed biosimilar to Sanofi-Aventis’ insulin glargine, with the reference product.