Bad news for Sanofi as biosimilar replaces Lantus

Sales of big-selling insulin, Lantus (insulin glargine) were already under pressure, but things have got much worse for Sanofi, now a major US pharmacy benefit manager has axed the big-seller in favour of a biosimilar.

CVS axed Lantus from its list of medicines it reimburses on behalf of health insurers, and replaced it with Lilly/Boehringer Ingelheim’s biosimilar, Basaglar.

In CVS’ 2017 formulary, Novartis’ Tasigna (nilotinib) blood cancer drug was axed and replaced with the older Gleevec (imatinib), as well as an orphan pulmonary arterial hypertension drug from Actelion. CVS has also axed Sanofi’s next generation, longer acting version of Lantus, Toujeo.

Approved by the FDA at the end of last year, Basaglar is a near-copy of Lilly’s cash cow, which has lost patent protection in the US.

Q2 figures last week showed sales of Lantus have already fallen by 11.2% in constant currency terms to $1.47 billion – but the CVS decision shows the rot is truly setting in for Sanofi.

CVS’ decision also illustrates how many big-name branded manufacturers aim to use biosimilars to steal market share from their rivals.

They are more expensive to research and produce than generics, but nevertheless can still be sold at a substantial discount compared with the branded original.

At a time when drug pricing is under scrutiny, and healthcare budgets in developed countries are under pressure, ditching expensive drugs is an easy way to bring savings that can free up money to be spent elsewhere, or increase the number of patients accessing the medicine.

An FDA decision is due this month on Sanofi’s Lixilan (insulin glargine+lixisenatide), combining Lantus with Sanofi’s GLP-1 drug. Thomson Reuters Cortelis consensus figures predict sales in excess of $1 billion by 2020.

Lixilan got a glowing recommendation from the FDA’s panel of diabetes drug advisers a few weeks ago – but they also gave a decisive "yes" vote for Novo Nordisk’s rival, iDegLira (insulin degludec+liraglutide).

Even with a likely strong product like Lixilan, Sanofi is not getting a clear run at the US diabetes market.

Yesterday's news sent Sanofi’s shares down and possibly weakened its position in negotiations with acquisition target and cancer drug specialist, Medivation.