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Latest From Viatris Inc.

Biocon Waits On FDA Insulin Inspection

Biocon is awaiting a scheduled FDA pre-approval inspection for insulin aspart at its facility in Malaysia, amid concerns that the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.

Biosimilars Sales & Earnings

The Wait For Inspections: Biocon Seeks FDA Stance On Mutual Recognition Agreement Route

Biocon is awaiting a scheduled FDA pre-approval inspection for insulin aspart at its facility in Malaysia, amid concerns that the surge in COVID-19 cases in the Southeast Asian nation may cloud timelines. The Indian firm is also pursuing a mutual recognition agreement route with the agency for a generic product approval.

Biosimilars Regulation

TB Alliance CEO On Less Toxic Treatment Regimens, Pretomanid Plans

TB Alliance CEO Mel Spigelman discusses a range of new and evolving aspects pertaining to the three-drug BPaL regimen for highly drug-resistant TB, including the ZeNix trial results and adding a licensee for pretomanid. He also notes how COVID-19 has had a “terrible impact” on efforts to tackle the TB pandemic.

Research & Development Clinical Trials

Interchangeable Biosimilars: Insulin Likely First But Humira May Be More Important Precedent

US FDA’s first decision on biosimilars interchangeability might have less meaning for two insulin products, but payer and prescriber responses to interchangeable biosimilars for adalimumab, which are further out on the horizon, may be more instructive regarding the importance of interchangeability status.

Biosimilars Reimbursement
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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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