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Latest From Alvotech

Alvotech Suffers Delay On Higher-Strength Adalimumab In US

Alvotech has suffered a setback in its attempt to gain the first US FDA approval for a higher-strength biosimilar adalimumab rival to Humira, after obstacles preventing facility inspections led the agency to defer action on the firm’s AVT02 candidate.

Biosimilars Regulation

BeiGene’s Brukinsa Among Nine Drugs To Win EU Marketing Thumbs Up

A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval. 

Europe Approvals

Alvotech And Stada Gain Second Ever Higher-Strength Adalimumab Nod

Alvotech and Stada are on the verge of gaining the world’s second ever approval for a higher-strength Humira biosimilar, after the EMA’s CHMP endorsed the firms’ adalimumab under the names Hukyndra and Libmyris at its September meeting.

Biosimilars Europe

BeiGene’s Brukinsa Among Five Orphan Drugs Awaiting EU Approval Verdict

Sponsors of several new medicines are set to learn if their products are on track for pan-EU approval. One product on the list is Pfizer/Lilly’s osteoarthritis drug, tanezumab, which recently ran into trouble in the US.

Drug Review Approvals
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Company Information

  • Industry
  • Pharmaceuticals
    • Generic Drugs
  • Biotechnology
    • Synthesis Technologies, Production Processes
    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • Alvotech Iceland
    • Alvotech Germany GmnH
    • Alvotech Swiss AG
    • Glycothera
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