Lytenava (bevacizumab)
Additional monitoring
- Region
- 🇪🇺 EU
- Active substance
- bevacizumab
- Company
- Outlook Therapeutics NL B. V.
- Status
- Authorised
- Therapeutic area
- Wet Macular Degeneration
- CHMP opinion
- Thu 21 Mar 2024
- EU approval
- Mon 27 May 2024
- Designations
- Additional monitoring
- Application
- EMEA/H/C/005723
- ATC
- S01LA08
- Official record
- www.ema.europa.eu
Indication
Lytenava is indicated in adults for treatment of neovascular (wet) age-related macular degeneration (nAMD).
Regulatory milestones
Fri 24 Jul 2026🇺🇸 FDA approval
FDA approves biosimilar Lytenava (bevacizumab-vikg)
Outlook Therapeutics, Inc.; BLA761320; Biosimilar; vial · source
Same substance in other markets
- 🇪🇺 Mvasi Authorised · Amgen Europe B.V.
- 🇪🇺 Aybintio Authorised · Samsung Bioepis NL B.V.
- 🇪🇺 Orblid Application withdrawn · Laboratoires Delbert
- 🇪🇺 Abevmy Authorised · Biosimilar Collaborations Ireland Limited
- 🇪🇺 Zirabev Authorised · Pfizer Europe MA EEIG
- 🇪🇺 Avzivi Authorised · FGK Representative Service GmbH
- 🇪🇺 Alymsys Authorised · Mabxience Research SL
- 🇪🇺 Oyavas Authorised · STADA Arzneimittel AG
- 🇪🇺 Vegzelma Authorised · Celltrion Healthcare Hungary Kft.
- 🇪🇺 Avastin Authorised · Roche Registration GmbH
- 🇪🇺 Onbevzi Withdrawn · Samsung Bioepis NL B.V.
- 🇪🇺 Ipique Refused · Rotterdam Biologics B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.