European Commission Grants Lilly and Boehringer Ingelheim's Insulin Glargine Product Marketing Authorisation in Europe
The European Commission (EC) granted marketing authorisation for Eli Lilly and Company and Boehringer Ingelheim's insulin glargine product, indicated to treat diabetes in adults, adolescents and children aged 2 years and above. Lilly/Boehringer Ingelheim's insulin glargine product is the first insulin treatment approved through the European Medicines Agency's biosimilar pathway and the fourth diabetes product approved in the EU from the Lilly-Boehringer Ingelheim Alliance. It received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) on June 26, 2014.
"The marketing authorisation for this insulin glargine product in Europe is a significant achievement for the Lilly–Boehringer Ingelheim Alliance. We believe that insulin glargine will continue to be widely used for many years, and Lilly and Boehringer Ingelheim are committed to addressing the needs of people living with diabetes and providing support beyond the medicine," said Enrique Conterno, President, Lilly Diabetes.
The alliance's insulin glargine product is a basal insulin with the same amino acid sequence as Lantus (insulin glargine) and is intended to provide long-lasting blood sugar control between meals and at night. Lilly/Boehringer Ingelheim's insulin glargine product will be available in a pre-filled pen and cartridges for a reusable pen.
"Basal insulin is an important mainstay of treatment for people with type 1 and type 2 diabetes, and we're pleased that Lilly/Boehringer Ingelheim's insulin glargine product will provide healthcare professionals and patients with another option to meet their insulin treatment needs, along with significant expertise and support from the Lilly-Boehringer Ingelheim Alliance," said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.
The marketing authorisation for the Alliance's insulin glargine product is based upon a comprehensive clinical data programme, which showed it has similar efficacy and safety compared to the currently marketed insulin glargine product in people with type 1 and type 2 diabetes. The application included results from pharmacokinetic and pharmacodynamic studies, as well as Phase III studies in patients with type 1 and type 2 diabetes.
While 'Abasria' is an approved name in Europe, it's not necessarily approved in other regions. Lilly and Boehringer Ingelheim are targeting a global trade name for the Alliance's insulin glargine product, which will be announced at a later date.
Lilly/Boehringer Ingelheim's insulin glargine product will be manufactured by Lilly, which has been manufacturing insulin since 1923. This history gives Lilly extensive expertise, insights and knowledge in the insulin space, enabling it to provide high quality medicines to diabetes patients worldwide.
Related News
-
News Patients vs Pharma – who will the Inflation Reduction Act affect the most?
The Inflation Reduction Act brought in by the Biden administration in 2022 aims to give better and more equitable access to healthcare in the USA. However, pharma companies are now concerned about the other potential costs of such legislation. -
News CPHI Podcast Series: What does the changing US Pharma market mean for industry and patients alike?
In this week's episode of the CPHI Podcast Series Lucy Chard, Digital Editor for CPHI Online is joined by James Manser to discuss the political and market changes in the US pharma field. -
News CPHI Barcelona Annual Report illuminates industry trends for 2024
The CPHI Annual Survey comes into it’s 7th year to report on the predicted trends for 2024. Over 250 pharma executives were asked 35 questions, with their answers informing the industry landscape for the next year, spanning all major pharma marke... -
News Which 10 drugs are open to price negotiation with Medicare in the USA?
The Centres for Medicare & Medicaid Services, under the Biden administration in the USA, has released a list of the 10 drugs that will be open to price negotiations as part of the new legislation under the Inflation Reduction Act (IRA). -
News EU Medical Devices Regulation causes unintended disappearances of medical devices for children, doctors state
Doctor groups and associations have appealed to the EU to correct the EU Medical Devices Regulation law that may cause unintended shortages of essential drug and medical devices for children and rare disease patients. -
News 10 Major Drug Approvals So Far in 2023
Last year, 37 novel drugs were approved by the FDA, this was a high number for such a category, and covered many fields including oncology, demonstrating how promising further research is, and how it is only continuing to build. To date, there are alre... -
News Detecting Alzheimer's disease with a simple lateral flow test
A novel rapid diagnostic test for early-stage Alzheimer's disease has been developed using a biomarker binder from Aptamer Group along with technology from Neuro-Bio, the neurodegenerative disease experts. -
News CPHI Podcast Series: outsourcing and manufacturing trends
Listen to the CPHI Podcast Series this June to hear Gil Roth of the PBOA speak with Digital Editor Lucy Chard about the biggest trends and topics to watch in pharma outsourcing and manufacturing at the minute.
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