Alymsys / Oyavas
Bevacizumab biosimilar developed by mAbxience, development code MB02. Reference product Avastin.
Brands by market: Alymsys (USA, EU); Oyavas (EU) · Commercial partner or holder: Amneal (USA); Stada (EU, Oyavas)
FDAApr 2022approved
EMAMar 2021authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Alymsys
US Food and Drug AdministrationApprovedBrand
Alymsys
Holder or applicant
Amneal Pharmaceuticals LLC
Pathway
351(k)
Approved
Apr 2022
Application or permission
761231
Licence type
351(k) biosimilar, not interchangeable
Presentations
100 mg/4 mL, 400 mg/16 mL
Source
S001, S016
EMA
European Union · Alymsys
European Medicines Agency and European CommissionApprovedBrand
Alymsys
Holder or applicant
Mabxience Research SL
Pathway
Centralised (Article 10(4))
Approved
Mar 2021
Application or permission
EMEA/H/C/005286
Presentations
see SmPC
Source
S017
EMA
European Union · Oyavas
European Medicines Agency and European CommissionApprovedBrand
Oyavas
Holder or applicant
STADA Arzneimittel AG
Pathway
Centralised (Article 10(4))
Approved
Mar 2021
Application or permission
EMEA/H/C/005556
Presentations
see SmPC
Note
Stada licence of the mAbxience product.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAMar 2021Authorised by the European Commission as Alymsys
- EMAMar 2021Authorised by the European Commission as Oyavas
- FDAApr 2022Approved by FDA as Alymsys
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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