Mylan and its partner Biocon have received a Complete Response Letter from the FDA in regard to their application for a follow-on insulin glargine referencing Lantus.
Recently, the American Diabetes Association (ADA) released a set of policy recommendations to improve patient access to much-needed insulin and to lower the substantial cost to treat diabetes. 
An Asian study comparing the quality of glycemic control among patients using biosimilar insulin with those using originator insulin found no independent association of biosimilar insulin with differences in indicators of glycemic control—glycated hemoglobin, insulin dosage, or hypoglycemia.
Mylan’s insulin glargine follow-on, MYL-1501D, referencing Sanofi’s Lantus, is a long-acting human insulin analogue that allows for once-daily basal use in patients with type 1 diabetes. The drug has been authorized for marketing as a biosimilar insulin in the European Union and in Australia under the brand name Semglee.
Sanofi’s list prices for Admelog are approximately 15% lower than the originator Humalog’s prices.
The biosimilar insulin will be sold under the brand name Semglee in a 100 IU/mL 3mL prefilled pen presentation in both territories. Mylan and Biocon say that they plans to launch the product in various markets in Europe in the second half of 2018, and in Australia “later this year.”
On Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on and recommended a marketing authorization for Mylan and Biocon’s Semglee, an insulin glargine follow-on that will be available in the European Union as a solution for injection for patients with diabetes.
SAR342434, or Admelog, a follow-on of insulin lispro (Humalog), showed similar efficacy, safety, and immunogenicity to its reference in patients with type 2 diabetes who also used insulin glargine (Lantus) as basal insulin, according to the results of the SORELLA-2 study, published in the January 2018 issue of Diabetes Technology & Therapeutics.
Antagonism of tumor necrosis factor-alpha (TNF-alpha) may be a good treatment strategy to counter the deleterious effects of TNF-alpha on the development of insulin resistance and the pathogenesis of type 2 diabetes.
Australian biosimilar developer NeuClone has announced that it is developing a proposed biosimilar denosumab (referenced on Amgen’s Prolia, Xgeva).

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