Labels The Issue For Viatris Again As It Recalls Insulin Glargine Biosimilar
Bernstein: Recall Could ‘Spell Problem’ For Biocon-Manufactured Product
A further voluntary recall for Viatris’ insulin glargine biosimilar, this time for one of its recently launched interchangeable products, because of missing labels may draw unwanted interest from the US FDA, a leading analyst has warned.
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Viatris has recalled a batch of its unbranded insulin glargine injector pens after a manufacturing error meant some pens might be missing labels. It is the third time this year the firm has had to recall an insulin product due to a labelling error.
Craig Burton, who replaces the FDLI-bound Christine Simmon, tells the Pink Sheet that fighting rebating practices which harm insulin patients now can pave the way for successful launches of Humira biosimilars next year. Biosimilar markets should not be ‘winner-take-all,’ he says.
Lannett has delivered on its promise of kicking off a pivotal clinical trial for its proposed interchangeable biosimilar rival to Lantus by the end of March, as it eyes a 2023 filing and 2024 launch in the US for the insulin glargine product on which it has partnered with HEC.