The US Food and Drug Administration (FDA) has approved Sanofi's human insulin analog biosimilar, Merilog.
The subcutaneous Novolog biosimilar — which is suitable for both adult and paediatric diabetics — can be used to improve glycaemic control and is the first fast-acting insulin biosimilar to be approved by teh US regulatory board.
Merilog is designed to lower blood sugar spikes, improving blood sugar control in this patient population.
Through this agreement, Sanofi can seel both a 3 mL single-use prefilled pen, as well as a 10 mL multiple-dose vial.
Merilog is the third insulin biosimilar to be approved by the FDA, as two long-acting insulin products in the biosimilar category were approved in 2021.
Enhancing patient accessibility
With more than 38 million people currently living with diabetes in the US and 8.4 million of those relying on insulin therapy, there is a clear need for insulin products to fulfil this patient need.
The approval of biosimilars such as Merilog can assist patients in accessing such therapies at affordable prices, while also ensuring the supply chain is robust.
“The FDA has now approved three biosimilar insulin products to treat diabetes,” said Peter Stein, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research.
“Today’s approval 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," he commented.
"Increasing access to safe, effective and high-quality medications at potentially lower cost remains a continued priority for the FDA.”
“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 in the FDA’s Center for Drug Evaluation and Research.