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.

Vieriu Adrian/Alamy Stock Photo
Will the FDA take an interest in Viatris' latest recall? • Source: Alamy (Vieriu Adrian / Alamy Stock Phot/Alamy Stock Photo)

Viatris Inc. had only three months ago voluntarily recalled a batch of its insulin glargine biosimilar prefilled pens, the result of missing labels that, it was warned, could lead to a mix-up of products/strengths and potential administration of the wrong insulin to patients.

Now the US-based firm has recalled another batch – this time, one of its recently launched interchangeable biosimilar products, the...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Biosimilars

Regulatory Recap: FDA Starts ‘Radical Transparency’ Era After Publishing Over 200 CRLs

 

Generics Bulletin reviews global regulatory developments across the world.

Industry Welcomes Support From UK Life Sciences Plan

 
• By 

A new life sciences strategy unveiled by the UK government has won plaudits from the off-patent industry for its inclusion of measures specifically geared towards generics and biosimilars – especially a £1bn savings target linked to biosimilar uptake.

Adalvo Changes Hands As EQT Takes Control

 
• By 

Private equity firm EQT is taking control of Alvo group B2B business Adalvo, after striking a deal to acquire a majority stake from Aztiq, the investment vehicle of founder Róbert Wessman.

Bio-Thera Matches Alvotech With US Golimumab Filing Acceptance

 
• By 

Bio-Thera is one step closer to launching a biosimilar to Johnson & Johnson’s Simponi in the US, following FDA acceptance of its BAT2506 proposed golimumab candidate.

More from Products

FTC’s Latest Effort To Dispute Improper Patent Listings Barely Made A Dent

 

Trump’s FTC has carried on two legacies – trying to eliminate improper drug patent listings and making minimal impact on such efforts.

Amphastar Unveils Plans To Quadruple US Manufacturing

 
• By 

Amphastar has announced plans to quadruple its domestic production capacity over the next three to five years. The move plays into a growing trend towards US manufacturing localization, against the backdrop of potential pharmaceutical tariffs being mooted by the Trump administration.

Bio-Thera Matches Alvotech With US Golimumab Filing Acceptance

 
• By 

Bio-Thera is one step closer to launching a biosimilar to Johnson & Johnson’s Simponi in the US, following FDA acceptance of its BAT2506 proposed golimumab candidate.