- Sanofi SA notched a much-needed win for its diabetes business on Tuesday, securing Food and Drug Administration approval for a follow-on treatment to Eli Lilly & Co.'s blockbuster insulin Humalog.
- While the French pharma hasn't disclosed pricing details, it does plan on providing more information when its new drug, which will to be sold under the brand name Admelog, launches in early 2018, a company spokesperson told BioPharma Dive.
- Admelog went through the FDA's abbreviated approval pathway, which allows a biologic under review to draw on efficacy and safety information from a previously approved and highly similar product. The pathway came as part of the Biologics Price Competition and Innovation Act of 2009, and can help reduce development expenses for drugmakers — savings that, at least in theory, would then trickle down to consumers.
Admelog (insulin lispro)'s approval comes at an opportune time for Sanofi. The diabetes treatment space has become incredibly crowded, and pricing pressures are weighing heavily on bottom lines. During the third quarter, the company saw €1.55 billion ($1.82 billion) in global diabetes sales, down 10% year over year.
Sanofi attributed the unit's decline to a weaker U.S. performance of its long-acting drug Lantus (insulin glargine), and anticipated the tumble would continue in the fourth quarter due in part to formulary exclusions at CVS Health Corp. and UnitedHealth Group Inc.
Adding a Humalog follow-on to the mix gives Sanofi a helpful tool to offset some of those setbacks. Between June and September, the insulin raked in nearly $700 million for Lilly. What's more, insulin lispro is a fast-acting insulin, meaning it adds a dose of diversity to Sanofi's diabetes portfolio, which gets most of its revenue from longer-acting treatments.
"Complementing our existing insulin portfolio, Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime," Stefan Oelrich, head of Sanofi's global diabetes and cardiovascular, division, said in a Dec. 11 statement from the company.
Lilly, meanwhile, has maintained a cool composure as Sanofi works to chip away at its top-seller.
"Thus far, the loss of compound patent protection for Humalog has not resulted in a rapid and severe decline in revenue," Lilly wrote in its third quarter filing with the Securities and Exchange Commission. "While it is difficult to estimate the severity of the impact of similar insulin lispro products entering the market, we do not expect a rapid and severe decline in revenue; however, we expect competitive pressure and some loss of market share initially that would continue over time."