Hikma gets FDA nod for generic Victoza, launches 2 new generics
Hikma recently received the Food and Drug Administration’s permission for a new generic, and the company also launched two new generic products.
The FDA approved Hikma's first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with Type 2 diabetes as an adjunct to diet and exercise.
The FDA approved the first generic in this class of medications last month with the approval of a generic referencing Byetta (exenatide).
"The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications," said Iilun Murphy, M.D., director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research. "Generic drugs provide additional treatment options which are generally more affordable for patients. Today's approval underscores the FDA's continued commitment to advancing patient access to safe, effective and high-quality generic drug products."
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Liraglutide improves blood sugar levels by creating similar effects in the body as GLP-1 in the pancreas, which is often found in insufficient levels in Type 2 diabetes patients. According to the Centers for Disease Control and Prevention, more than 38 million Americans have diabetes, and 90% to 95% of those individuals have Type 2 diabetes, the FDA said.
“We are very pleased to launch Liraglutide Injection immediately upon receiving U.S. FDA approval, providing U.S. healthcare professionals and patients with this important generic treatment of diabetes,” said Bill Larkins, president of injectables at Hikma. “This launch is the latest example of our actions to expand our portfolio in growing therapeutic areas like diabetes and to provide customers and patients with affordable access to a reliable supply of high-quality essential medicines.”
Hikma also recently launched ePHEDrine sulfate injection, in a 25 mg/5ml dosage. The product is in a prefilled syringe and is indicated for the treatment of clinically important hypotension occurring in the setting of anesthesia.
ePHEDrine sulfate injection, 25 mg/5ml, had a market value of approximately $17 million in the 12 months ending October 2024, per IQVIA.
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Hikma also released indomethacin suppositories, in a 50 mg dose, which is the second generic on the market.
The product is indicated for:
- Moderate to severe rheumatoid arthritis including acute flares of chronic disease
- Moderate to severe ankylosing spondylitis
- Moderate to severe osteoarthritis
- Acute painful shoulder (bursitis and/or tendinitis)
- Acute gouty arthritis
Indomethacin suppositories, 50 mg had a market value of approximately $57 million in the 12 months ending October 2024, per IQVIA.