EMA has published the revised guideline on biosimilar insulins

The European Medicines Agency has finally issued the final version of its revised guideline on biosimilar products containing recombinant human insulin and insulin analogues, after a consultation process that lasted more than two years.

The first version of 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 more than 2 years ago, in December 2012. In April  2014, the Agency published a second draft version which was open for comments till the end of July 2014.

Although the guideline was published almost 9 years ago, there is only one approved insulin biosimilar 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 approved by the agency: Lilly, which is a major player in insulin market, together with its partner Boehringer Ingelheim, received the CHMP approval in June 2014.

Now the public consultation period is over and the new version of the biosimilar insulin guideline will come into effect on 1st of September this year. The second consultation on the guideline received comments from only four stakeholders; European Biopharmaceutical Enterprises, European Biosimilars Group (a sector group of the European Generic medicines Association), Wockhardt Ltd. and Medicines Evaluation Board of the Netherlands.

EMA has also published the overview of the comments which can be accessed from here.

And the revised guideline can be found here.