Generics Bulletin is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Latest From Alvotech

Alvotech FDA Approval Clears Path To Challenge Humira

Alvotech and US marketing partner Teva can now launch “imminently” their long-planned rival to Humira, with the firms believing that the Simlandi biosimilar will stand out from the crowd of other adalimumab challengers thanks to a unique combination of product attributes.

Biosimilars Approvals

Sandoz Enters Canada With First Denosumab Biosimilar

Sandoz has truly established its position as the frontrunner in the denosumab race after a Canadian approval, but the path to the US market has been hindered by a lawsuit from the originator Amgen.

Biosimilars Approvals

Philippines FDA Slashes Approval Timelines For Generic Drugs

The Philippines Food and Drug Administration is set to shorten the timeline for generic review and approval from 120 days to just 45 days, as part of efforts to register new generics and bring down prices.

Regulation Policy

Alvotech Clears A Path For 2024 Ustekinumab In Major Global Markets

Alvotech has ensured there won’t be any legal hurdles to overcome as it plots launches via commercialization partners for its AVT04 proposed biosimilar to Stelara in major global markets.

Europe Japan
See All

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
UsernamePublicRestriction

Register