Biosimilars are beginning to bite for Sanofi
- French drugmaker Sanofi reported higher-than-expected sales growth of 5.5% in the second quarter versus the same period a year prior, boosted by double-digit jumps in revenues from its Genzyme unit and vaccines business.
- Sales from its diabetes and cardiovascular business, however, fell by 15% due to biosimilar competition in Europe and formulary exclusions in the U.S.
- Sanofi recently launched Dupixent (dupilumab) and Kevzara (sarilumab), two immunology drugs it expects to be a cornerstone of future growth. While Dupixent only brought in sales of €26 million, Sanofi noted that over 5,100 physicians had prescribed Dupixent as of July 26.
While overall sales might be up, steepening declines from its diabetes and cardiovascular business continues to weigh on the drugmaker.
Sales of insulin glargine (Lantus and Toujeo) were down 23.9% in the U.S., following the exclusion of Lantus from both CVS' and United Health's formularies. The launch of Eli Lilly's Lantus biosimilar Basaglar in the U.S. last December has also had an impact, albeit small. Merck & Co.'s Lusduna Nexvue, while currently on hold under the Hatch-Waxman Act, could pose a future threat.
"We expect the sales decline to accelerate in the second half of 2017," said Sanofi CEO Olivier Brandicourt. "We will provide an update on the U.S. payer coverage in 2018 with the third quarter 2017 results."
Lovenox (enoxaparin) sales fell in the quarter by 2.4% overall, with a 7.3% fall in Europe also driven by the launch of a biosimilar.
"There has been one biosimilar to enoxaparin launched so far, and we expect that some others will be approved," said Brandicourt. "We have a high market share, and it is a competitive market. We see the biosimilars are just additional competitors, and we do expect acceleration of competition, both on volume and on price."
Amongst its new launches in the first half of the year, Sanofi trumpeted the €26 million ($30.6 million) sales for Dupixent (dupilumab), which was only approved in March. Dupixent has also had a positive opinion in Europe, where it is awaiting approval.
"This has only been on the market for four months. We have reached 5,100 prescribers so far, and we expect it to continue to grow," said Bill Sibold, EVP, Sanofi Genzyme.
While Dupixent and Kevzara are bright spots for Sanofi's immunology franchise, its efforts in oncology lag behind its rivals. The drugmaker does have a PD-1 inhibitor, SAR439684, in Phase 3 trials for first-line treatment non-small cell lung cancer, but, as AstraZeneca's recent miss in Mystic shows, success is all but guaranteed.
Sanofi, though, believes PD-1 inhibitors could end up proving more successful than the related PD-L1 blockers, of which Imfinzi is one.
"We have decided to focus on PD-1 as a mechanism, with biomarkers to help us to select the right population," said Elias Zerhouni, head of global R&D. "We believe that PD-1 is the right target, and we believe that it has potential to be superior to PD-L1. If we are successful we would be the second company to market with a PD-1 antibody for first-line NSCLC."
"Our aim is to begin with a submission for approval in metastatic cutaneous squamous cell carcinoma with our partner Regeneron based on the current Phase 2 data, and then follow up with a submission for NSCLC."
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