Eli Lilly and partner Boehringer Ingelheim say that regulators in Europe have accepted for review their biosimilar of Sanofi's blockbuster diabetes treatment Lantus.
The companies had filed a marketing authorisation application through the European Medicines Agency's biosimilar pathway for LY2963016 as a treatment for type 1 and 2 diabetes. The investigational long-acting insulin is similar to Lantus (insulin glargine), Sanofi's biggest-selling drug; in the first-quarter, its sales leapt 19.7% to 1.34 billion euros.
Lilly and Boehringer say they have studied LY2963016 "in a comprehensive clinical development programme in order to meet the highest standards of safety, efficacy and quality". They add that in addition to pharmacokinetic and pharmacodynamic studies, Phase III trials have been conducted "and results submitted", using Lantus as the active comparator.
Some analysts have expressed surprise at the extent of the clinical programme undertaken for a biosimilar. It has been claimed in some circles that an extensive data package has been submitted in a bid to boost Lilly and Boehringer's commercial prospects against Lantus, assuming their 'similar' drug gets approved.
Gwen Krivi, head of Lilly Diabetes product development, noted that long-acting insulin "is a mainstay treatment for many people with diabetes, and we anticipate that insulin glargine will continue to be widely used for many years to come".
Lantus will be going off-patent in the next couple of years but Sanofi has high hopes it can be replaced by an improved version, namely U300. Two Phase III studies were presented at the recent American Diabetes Association meeting in Chicago which demonstrated that U300 showed equivalent blood sugar control with fewer night-time low blood sugar events compared to Lantus.
Lilly CEO back at work
More good news for Lilly came with the announcement that chief executive John Lechleiter has returned to his duties after two months' medical leave following surgery for a dilated aorta.
His surgery and recovery were successful and he has been cleared to return to full-time work. Dr Lechleiter said that "I return to Lilly with renewed energy and enthusiasm, along with a new perspective on health and wellness and the critical importance of new medicines in advancing patient care".