• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Sanofi’s insulin biosimilar wins EMA committee recommendation

May 19, 2017 By Sarah Faulkner

Sanofi

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.”

Filed Under: Diabetes, Drug-Device Combinations, Featured, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: Sanofi-Aventis

IN CASE YOU MISSED IT

  • Medtronic unveils “MiniMed” as name for soon-to-be separated Diabetes unit
  • Insulet, Marvel collab to unveil comic book hero with type 1 diabetes
  • Insulet rolls out new Omnipod 5 iPhone app for use with Dexcom G7
  • Tandem, Abbott strike deal to pair insulin pumps with glucose-ketone monitor
  • Mosanna launches with $80M to support nasal spray for obstructive sleep apnea

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

Copyright © 2025 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Privacy Policy | RSS