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Latest From Viatris Inc.

Keeping Track: Enhertu, Nubeqa Grow With RTOR; Interchangeable Cimerli And Another Nuplazid CRL

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

United States US FDA Performance Tracker

Biocon Insulin Aspart US Opportunity: 'Not Completely Lost But Not The Best Situation'

Biocon may not be able to make it to the current contracting cycle in the US for its Viatris-partnered biosimilar aspart, but all is not lost, the management indicates. The Indian firm is also buoyant about the prospects of taking its franchise of potentially interchangeable recombinant human insulin to the US.

Biosimilars India

Biocon Insulin Aspart US Opportunity: 'Not Completely Lost But Not The Best Situation'

Biocon may not be able to make it to the current contracting cycle in the US for its Viatris-partnered biosimilar aspart, but all is not lost, the management indicates. The Indian firm is also buoyant about the prospects of taking its franchise of potentially interchangeable recombinant human insulin to the US.

Commercial Biosimilars

Cimerli Interchangeable Biosimilar Approved Without Switching Data

Citing low risk of a clinically impactful immunogenic response from systemic anti-drug antibodies and intraocular inflammation when alternating between Coherus’ Cimerli and Genentech’s reference product ranibizumab, US FDA says a switching study would not be informative.

Approvals Biosimilars
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Company Information

  • Industry
  • Pharmaceuticals
    • Generic Drugs
    • Drug Delivery
      • Transdermal
  • Other Names / Subsidiaries
    • Acton Pharmaceuticals, Inc.
    • Agila, Bioniche Pharma Holdings Limited
    • Alaven Pharmaceutical, LLC
    • Antula Healthcare AB
    • Bertek
    • Dow B. Hickham
    • Dow Hickam Pharmaceuticals, Inc.
    • Generics (UK) Ltd.
    • Jai Pharma
    • Madaus Pharma
    • Meda AB
    • Meda Pharmaceuticals Inc.
    • Mylan Inc.
    • Mylan Laboratories Limited (formerly Matrix Laboratories Limited)
    • Mylan Specialty (formerly Dey Pharma L.P.)
    • Rottapharm Madaus
    • Mylan Technologies, Inc.
    • UDL Laboratories
    • Viatris Inc.
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