EU biosimilar insulin guideline is ready for second consultation

May 9, 2014 4:16 PM

Europe’s drug watchdog, European Medicines Agency (EMA) surprisingly has put the draft guideline on biosimilar insulins for a second public consultation.

The document was originally published in February 2006 and came into force in June that year. EMA decided to update the guideline and the first release was almost a year and a half ago, in December 2012. Now, a new draft version is available and published on the agency’s website at the end of April which will be open for comments till the end of July 2014.

Although the guideline was published eight years ago, there are no insulin biosimilars in Europe to date. In December 2007 Marvel BioSciences withdrew its applications for three biosimilar products when the CHMP response included a number of questions related mainly to their comparability to Lilly’s Humulin. Marvel decided to make an another submission but in November 2012, the company withdrew applications for three biosimilars of Humulin S. According to the company, their products needed new bioequivalence data due to the changes of the EMA guideline.

Now, only one product is under evaluation at the agency: Lilly, which is a major player in insulin market, is now trying to get the approval of a biosimilar of their rival, Sanofi’s insulin glargine product Lantus. The submission was made in July 2013 and an opinion from the CHMP is expected in the upcoming months.

The second version of the draft guideline which has major changes in sections like clinical studies, pharmacodynamics, safety studies and extrapolation can be accessed from here.

Leave a Reply

Twitter ID
(ID only. No links or "@" symbols)

Latest News on Biosimilar News

Share an Article?

Writing an article is not only a great way to share your knowledge, but it is also a great way to give back to the community.

We value all our contributors and if you have a website, we will surely give a link back to your site and products.
Wanna contribute?


Biosimilar News was started for the people who are interested in this rapidly growing business area. So if you have suggestions or feedback on how we can improve, please let us know. If you want to see a specific topic covered, answer to a specific question, or anything else of this sort, just write us. We do our best to keep up!
Make a suggestion now!