"We expect results from the phase 4 study on itolizumab by the end of this quarter. This would be real-world data from around 300 patients," said Arun Chandavarkar, Managing Director of Biocon Biologics (Representative image)
The US Food and Drug Administration (USFDA) has approved Biocon-Viatris (formerly known as Mylan) Semglee- the first interchangeable biosimilar product, giving the designation to a once-daily insulin product to treat diabetes.
USFDA’s designation of Semglee (insulin glargine) as interchangeable with Lantus (insulin glargine of Sanofi) means that Semglee may now be substituted for the reference product at the pharmacy without the intervention of the prescriber.
Semglee is marketed by Biocon's partner Viatris in US. The biosimilar is manufactured by Biocon.
“This is a momentous day for people who rely daily on insulin for treatment of diabetes, as biosimilar and interchangeable biosimilar products have the potential to greatly reduce health care costs,” said acting USFDA Commissioner Janet Woodcock in the press release.
“Today’s approval of the first interchangeable biosimilar product furthers USFDA’s longstanding commitment to support a competitive marketplace for biological products and ultimately empowers patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost,” Woodcock added.
Allowing pharmacy-level substitution for this long-acting insulin has the promise of reducing the cost for a medicine used to improve glycemic control in millions of the 34 million people in the US, who have been diagnosed with Type 1 or Type 2 diabetes. The price of insulin in the US has risen sharply over the last decade, even as the incidence of Type 2 diabetes has continued an upward climb.
“Biosimilars marketed in the US typically have launched with initial list prices 15% to 35% lower than comparative list prices of the reference products,” wrote USFDA in announcing Semglee’s change in regulatory status.
Interchangeable biosimilars must be assessed by USFDA as being highly similar to their reference product, with no clinically meaningful differences in safety, purity or potency. Also, the same clinical result should be expected from use of either the interchangeable biosimilar or its reference product, with no difference in expected outcome between a patient who switched to Semglee from Lantus, compared to a patient who remained on Lantus for glycemic control.
Semglee was first approved as a human insulin analog in June 2020. FDA has released new material for health care providers to help them learn about interchangeable biosimilar products, including a new fact sheet dedicated to explaining the concept of an interchangeable biosimilar.