Sanofi (NYSE:SNY) said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended its insulin lispro biosimilar for approval.
Insulin lispro Sanofi is a biosimilar of insulin lispro, a fast-acting insulin analog made using recombinant DNA technology. Sanofi’s biosimilar has the exact same amino acid sequence as its reference product. The positive opinion from CHMP is Sanofi’s 1st major regulatory win for a biosimilar diabetes treatment.
The recommendation was supported by a clinical program that enrolled more than 1,000 patients with Type I or Type II diabetes. The program involved a pharmacokinetic/pharmacodynamic Phase I trial to compare the biosimilar to insulin lispro, a safety study using insulin pumps in adults with Type I diabetes and 2 Phase IIIa clinical trials.
“We welcome the CHMP positive opinion for Insulin lispro Sanofi and look forward to the final decision of the European Commission,” senior VP and global head of development, Dr. Jorge Insuasty, said in prepared remarks. “Our development of this investigational biosimilar product reflects Sanofi’s expertise and long-term heritage in developing and manufacturing high-quality insulins for people with Type I or Type II diabetes and their physicians.”
The European Commission is slated to make a final decision for the biosimilar in the coming months.
“Insulin lispro is an important and widely-used treatment for people with diabetes who require rapid control of their blood sugar at mealtime,” executive VP and GM of Sanofi’s diabetes & cardiovascular biz, Peter Guenter, added. “By broadening our portfolio of quality insulin options, we acknowledge our commitment to expand the affordability and sustainability of insulin treatments.”
