Are pharmaceutical brand names for cellular therapy products held to a different similarity review standard than pharmaceutical drug products? A recent approval may provide some answers as to how the FDA will review cellular therapies in the future.
The US FDA recently approved Lantidra, a cellular therapy product made from pancreatic cells of deceased donors, to treat type 1 diabetes. It’s specifically for adults with type 1 diabetes who struggle to control their blood sugar levels and experience frequent episodes of low blood sugar despite intensive diabetes management.
When the Brandsymbol Regulatory Division analyzed the name “Lantidra,” it reminded us of similar-sounding names like Apidra, Lantus, and Latuda. We checked their POCA scores in the chart below:
|Drug Name Pair||Combined Score (%)||Orthographic Score (%)||Phonetic Score (%)|
|LANTIDRA – Apidra||64||71||56|
|LANTIDRA – Lantus||62||68||55|
|LANTIDRA – Latuda||63||71||55|
POCA is a name safety testing tool that gives us a starting point, but we don’t rely on it alone when assessing name similarities. For name pairs with moderate POCA scores (between 54% and 69%), we need to consider other factors to determine the likelihood of confusion in real-world scenarios. We look at characteristics such as dosage form, strength, frequency, therapeutic category, and patient population.
In the case of Lantidra, both Apidra and Lantus are indicated for patients with diabetes mellitus, including adults and children. Apidra is a rapid-acting insulin analog, while Lantus is a long-acting insulin analog. These similarities raise concerns about potential confusion.
Latuda, on the other hand, is used to treat schizophrenia in adults and adolescents and bipolar depression in adults and pediatric patients. It carries warnings related to hyperglycemia, dyslipidemia, and weight gain.
While we don’t have confirmation, it’s possible that cellular therapy products undergo a slightly different similarity review process through the Center for Biologics Evaluation and Research (CBER) compared to pharmaceutical drug products reviewed by the Center for Drug Evaluation and Research (CDER). This difference may be similar to the separate name review process for vaccines and gene therapy, which is also handled by CBER due to the unique nature and administration of these products.
Administering Lantidra requires pre-procedural immunosuppression prior to infusion, and it must be administered directly into the hepatic portal vein by experienced interventional radiologists or surgeons in controlled, sterile conditions. Both the recipient’s serum and the donor’s lymphocytes must test negative to prevent immediate rejection of the islet cells.
As more cellular therapy products receive approval, we will continue to observe how the brand name review process adapts to these innovative treatments and keep you up to date on the latest trends in the pharmaceutical naming landscape.