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FDA Approves Second Interchangeable Lantus Biosimilar
Lilly’s Rezvoglar is a long-acting human insulin analog. It follows Semglee as a biosimilar that can be substituted for Lantus for both adults and children with diabetes.
The FDA has approved the second interchangeable biosimilar insulin product to Lantus (insulin glargine). Eli Lilly’s Rezvoglar (insulin glargine-aglr) is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with diabetes. FDA previously approved Rezvoglar as a biosimilar to Lantus on Dec. 17, 2021. An interchangeable status now allows Rezvoglar to be substituted for Lantus at the pharmacy level.
Related: FDA Approves First Interchangeable Biosimilar Insulin
Rezvoglar is the second approved interchangeable biosimilar insulin in the United States. Rezvoglar joins Viatris’ Semglee (insulin glargine-yfgn), the first approved interchangeable biosimilar to Lantus, that FDA approved on July 28, 2021. Payer acceptance of Semglee has been uneven. Prime Therapeutics and Express Scripts have added Semglee to their preferred formularies, but OptumRx has excluded Semglee.
Rezvoglar is available in 3 mL prefilled pens and is administered subcutaneously once daily. Rezvoglar may cause serious side effects, including hypoglycemia, severe allergic reactions, hypokalemia and heart failure. The most common side effects associated with insulin glargine products other than hypoglycemia include edema (fluid retention), lipodystrophy (pitting at the injection site), weight gain and allergic reactions, such as injection site reactions, rash, redness, pain and severe itching.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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Diabetes Management & Telehealth with Leslie Kolb
June 11th 2020Association of Diabetes Care and Education Specialists, chief science and practice officer, Leslie Kolb chats with MHE Associate Editor Briana Contreras in MHE's newest podcast Tuning into the C-Suite about diabetes management and how it's affected by the use of telehealth, especially during the current and trying times of the COVID-19 pandemic.
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Drugs to Watch: Mental Health Conditions
April 11th 2024The FDA is reviewing two novel therapies: a psychedelic-assisted therapy for PTSD with a target action date of Aug. 11, 2024, and therapy for schizophrenia that does not directly block dopamine receptors with an action date of Sept. 26, 2024.
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