Sanofi’s new insulin Toujeo is just months away from a European approval as the CHMP has recommended the drug for use across the continent.
Once-daily Toujeo (insulin glargine [rDNA origin]) is a next generation version of Sanofi’s blockbuster insulin Lantus, which has been bringing in more than $8bn a year for the firm.
But patents for Lantus are set to fall across key markets later this year, and rival big pharma firm Lilly is poised to release a biosimilar version of the treatment, which could cut its sales – although launch of the copycat has been delayed from its original May 2015 date.
Just how much of a threat the biosimilar will turn out to be remains to be seen, but Toujeo will be a key new treatment for the firm as falling sales of Lantus – and diabetes treatments in general – start to bite.
The CHMP, which is the safety and efficacy arm of the European Medicines Agency, has issued a positive opinion recommending the approval of Toujeo for patients with type 1 diabetes, as well as type 2 diabetes for those who have failed on oral antidiabetics.
Pierre Chancel, senior VP global diabetes at Sanofi, said: “This CHMP opinion is another step forward to make Toujeo available to people living with diabetes who are currently not at their glycemic target, or are about to start insulin therapy.
“We are confident that we can soon add this new treatment option to our portfolio to help patients reach their blood sugar goals.” The drug was also approved just last week by the FDA.
Analysts are warning that the drug will now face a pricing war with its own product, as well as any biosimilars and other new insulin products from rivals such as Novo Nordisk.
Sanofi has however made no secret of the fact that it will try to aggressively switch patients from Lantus to Toujeo – even if that means pricing the drug lower than it may like.
In fact its forecasts of even a slight growth in its diabetes franchise this year relies on that switch happening on a fairly major scale.
How Toujeo fares will be a major challenge for the new chief executive Olivier Brandicourt when he takes the helm in April – the same month the European Commission should give the final approval for the drug.