Viatris and the case of the missing insulin label is getting a second act.
Mylan Pharmaceuticals, now flying the Viatris banner, said Tuesday that it was recalling one lot of insulin glargine injection—the companies’ interchangeable biosimilar to Sanofi’s blockbuster diabetes med Lantus.
There’s a chance the label could be missing on some vials from the suspect batch, Viatris warned in a notice posted on the FDA’s website. Similar problems cropped up in January, when Mylan yanked one lot of non-interchangeable Semglee over fears of absent labels on certain prefilled pens.
Viatris markets several versions of the diabetes copycat: There’s the unbranded format, covered in this week’s recall notice, and a branded edition dubbed Semglee. The biosim’s interchangeability tag means either product—branded or generic—can be subbed for Sanofi’s med at the pharmacy counter with a prescription, much like the process for small-molecule generics. The non-interchangeable Semglee behind January’s recall is separate from the two interchangeable products.
As for the latest labeling snafu, Viatris said the affected lot was manufactured by India's Biocon and distributed nationwide by Mylan Specialty between Dec. 9 and March 4. The batch, which contains cartons of 10-ml Semglee vials, was due to expire next August. Viatris did not say how many total vials were swept up in the recall.
Viatris formed in late 2020 through the fusion of Mylan and Pfizer's Upjohn established medicines unit.
The label glitch could pose a risk to patients taking more than one type of insulin, Viatris pointed out. If a label is MIA, a patient could confuse products or product strengths, which could lead to subpar glycemic control that in turn could trigger serious health complications.
As of Tuesday, Viatris said it hadn’t received any safety reports tied to the recall.
Meanwhile, the company stressed that the recall doesn’t extend to branded, interchangeable Semglee.
The drug bagged its first green light in June 2020 but, at the time, lacked the interchangeable distinction. That came the following summer, when the FDA approved the med as the first interchangeable biosimilar. The tag, in theory, should help boost access and reduce costs for patients, physicians, payers and providers, Michael Goettler, Viatris’ CEO, said in a statement last year.
As for the rationale behind Viatris’ synchronized branded and unbranded launches of the med, the company is essentially leveraging an unusual pricing strategy to pick up market share.
Brand-name Semglee is only slightly cheaper than Lantus, while the unbranded, interchangeable version costs around 65% less than Sanofi’s med, a Viatris spokesperson told Fierce Pharma last year.
By launching two versions of the same product, Viatris is effectively giving payers the option to choose between a high-price, high-rebate product or another that carries a lower price and features a lower rebate, Bernstein analyst Ronny Gal explained at the time.