First biosimilar fast-acting insulin reaches US market
A Sanofi subsidiary has claimed FDA approval for the first biosimilar of Novo Nordisk's Novolog, an older formulation of the Danish pharma's blockbuster insulin analogue product insulin aspart.
Sanofi-Aventis' Merilog version of the product has been cleared for the treatment of adult and paediatric patients with type 2 diabetes. It is the first biosimilar of a rapid-acting insulin product – used to control the blood glucose spike after meals – and only the third insulin biosimilar to be approved in the US.
Novo Nordisk's insulin aspart franchise is a DKK 10.6 billion ($1.5 billion) business worldwide, with NovoLog (known as NovoRapid outside the US) making up the bulk (around DKK 9 billion) of global sales. The US is, in turn, the largest contributor, with sales there of around DKK 7.5 billion last year.
Novo Nordisk has developed a new version of the insulin analogue, called Fiasp, which added another DKK 1.6 billion to the fast-acting insulin pot last year and has patent protection to 2030.
Peter Stein, director of the Office of New Drugs in the FDA's Centre for Drug Evaluation and Research (CDER), said the approval of the third biosimilar insulin "highlights our continued efforts to improve the efficiency of the biosimilar approval process to help support a competitive marketplace and increase options for costly treatments, like insulin."
Merilog has been cleared in a 3ml single-patient-use prefilled pen, and a 10ml multiple-dose vial should be administered by subcutaneous injection within five to 10 minutes before the start of a meal. NovoLog is also available in pen injector formats.
Before Merilog, the FDA has given the go-ahead to two biosimilars of Sanofi's basal insulin product Lantus (insulin glargine) – Viatris' Semglee and Eli Lilly's Rezvoglar – which are used to provide a background level of insulin over the course of the day and reached the market in 2021.
The biosimilars reach the US market as the US insulin space has seen seismic changes in the last few years, with a clamour of calls for price cuts that have led the big producers to slash prices for some of their older products and the introduction of a mandatory $35 monthly insulin copay cap for Medicare.
While a few years ago, the loss of patent protection for a big insulin brand would have been a deal for Novo Nordisk, surging sales of the GLP-1 agonist class of diabetes therapies like Ozempic (semaglutide) have reduced the impact.
The company is in the process of removing older insulin products from the market, in part so it can divert manufacturing capacity for newer, growth products in its GLP-1 stable.
More than 38 million people in the US have been diagnosed with diabetes, and about 8.4 million Americans rely on insulin therapy.
"For the millions of people who rely on daily injections of insulin for treatment of diabetes, having a biosimilar option for their rapid-acting insulin injection can truly make a difference, as biosimilar products have the potential to increase access to these life-saving medications," said Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars at CDER.
