After nearly seven months and two prior recalls, Viatris continues to be vexed by labeling issues on its biosimilar to Sanofi’s diabetes blockbuster Lantus.
Viatris’ Mylan this week said it was once again recalling a solo batch of insulin glargine injection over the potential for the label to be missing on some prefilled pens. Similar issues cropped up back in January and then again in April, with recalls following in both cases.
The batch covered under this week’s recall comprises 3-ml prefilled pens, which come in cartons of five, Viatris said in a release. The company emphasized that the market pull relates specifically to unbranded insulin glargine rather than Viatris’ branded Lantus biosim Semglee.
Viatris markets several versions of the diabetes medication. Both the unbranded and branded format, dubbed Semglee, boast interchangeability tags, which means they can be substituted for Sanofi’s med at the pharmacy counter.
As for the latest recall, the absent label could lead patients on multiple types of insulin—both short- and long-acting insulin, for example—to mix up products and strengths. That could in turn result in subpar glycemic control, which could then lead to serious health complications, Viatris said in a release.
As of Tuesday, July 5, Viatris said it hadn’t received any side effect complaints or safety flags linked to the recall.
The suspect insulin glargine lot was manufactured by India’s Biocon and distributed by Mylan Specialty across the U.S. between April 4 and May 5. Viatris didn’t say how many five-pen cartons were contained in the batch, which was due to expire in August 2023.
The saga of Viatris and the missing insulin label has been rolling along since January, when the company first revealed it was yanking a single batch of non-interchangeable insulin glargine injection for the same reason.
A similar recall followed in April. As with the latest recall, April’s market withdrawal concerned unbranded, interchangeable insulin glargine, rather than branded Semglee.
After an initial green light in 2020, Viatris’ med won approval from the FDA last summer as the first interchangeable biosimilar.