On November 16, the Food and Drug Administration (FDA) granted its second interchangeable designation to an insulin glargine product, Rezvoglar®, manufactured by Eli Lilly. Rezvoglar was first approved as a biosimilar in December 2021.
Viatris’ Semglee® was the first glargine product given the interchangeable designation, in July 2021 (it was originally approved as a 505(b)2 agent, not a biosimilar).
Both products are considered interchangeable with the reference product Lantus® only. This category is extremely competitive; in addition to the interchangeable insulins, there is a follow-on agent (Lilly’s Basaglar®), an authorized low-cost biosimilar (a nonbranded version of Semglee), other long-acting insulin brands (e.g., Toujeo®), and the anticipated entry of another low-cost biosimilar from Civica in 2024.
In other biosimilar news
More real-world evidence is being compiled on the safety and efficacy of switching noninterchangeable biosimilars. The latest comes from a review of prospective trials, observational studies and case reports conducted on adalimumab, infliximab, and etanercept biosimilars used for the treatment of psoriasis. The data were largely from Europe, of course, as adalimumab and etanercept biosimilars were not available in the US at the time of the analysis.
The authors conclude, “Efficacy and safety profiles of adalimumab, etanercept, and infliximab biosimilars are similar to those of the reference products in real-world use, supporting the practice of switching patients from these biologics to approved biosimilars when possible. The real-world evidence is consistent with controlled trials and may be reassuring to patients and providers.”