First Biosimilar Insulin to Receive CHMP Positive Opinion in the EU
The Committee for Medicinal Products for Human Use (CHMP) today issued a positive opinion recommending approval for the investigational compound LY2963016, a new insulin glargine product, for the treatment of type 1 and type 2 diabetes. The new insulin glargine product from Eli Lilly and Company and Boehringer Ingelheim (BI) is the first biosimilar insulin recommended for approval in the European Union (EU).
Lilly/BI's insulin glargine is a basal insulin, which is intended to provide long-lasting blood sugar control between meals and at night, an integral part of glycemic control.1 It has the same amino acid sequence as Lantus (insulin glargine) and was filed through the European Medicines Agency's (EMA) biosimilar pathway.
As the term is a regulatory designation, Lilly/BI's insulin glargine is considered a biosimilar in some regions, including Europe, but not in others, including the US.
"The CHMP's recommendation brings us a step closer to providing an important new option for the millions of patients in the EU who need basal insulin to help manage their diabetes," said Enrique Conterno, president, Lilly Diabetes. "This first-ever biosimilar insulin to receive a positive CHMP recommendation underscores Lilly and Boehringer Ingelheim's commitment to providing physicians and patients high-quality diabetes medicines, along with expertise and support tools they need to help manage the disease."
The CHMP's recommendation is based on the companies' non-clinical and clinical development programme, which included pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in patients with type 1 and type 2 diabetes. The European Commission's final decision is expected in approximately 2 months. If approved for marketing authorisation, Lilly/BI's insulin glargine would be the fourth diabetes product in the Lilly-Boehringer Ingelheim Diabetes Alliance to receive regulatory approval in the EU.
Lilly has been manufacturing insulin since 1923, and remains committed to innovation in insulin therapy, introducing many insulin products and delivery devices in the last nine decades. This history gives Lilly extensive expertise, insights and knowledge in the insulin space, enabling it to provide high quality medicine to diabetes patients worldwide.
Reference
1. Inzucchi SE, Bergenstal RM, et al. Management of Hyperglycemia in Type 2 Diabetes: A Patient-Centered Approach. Diabetes Care June 2012 vol. 35 no. 6 1364–1379.
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance