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) · Company profile
FDAApr 2022approved
EMAMar 2021authorised
MHRALicenseddate not shown
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 3 of 7 markets
Connections
About Alymsys / Oyavas
Alymsys is the bevacizumab developed by mAbxience of Spain, approved in Europe in 2021 and in the United States in 2022, where it is sold by Amneal. In Europe it also carries a second name, Oyavas, under a licence to Stada. mAbxience was the first Spanish company to bring an antibody biosimilar to market.
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
Reference product in the Purple Book
Avastin
Marketing status (Purple Book)
Prescription, marketed
Presentations
100 mg/4 mL, 400 mg/16 mL
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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) · checked Sep 2026
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
Remarks
Stada licence of the mAbxience product.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Alymsys
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Alymsys
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
25 mg/mL vials
Source
S023 (MHRA Products) · checked Sep 2026
MHRA
United Kingdom · Oyavas
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Oyavas
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
25 mg/mL vials
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Alymsys / Oyavas by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| MB02 | mAbxience | Avastin | Phase 1 | Comparative PK | Completed | Aug 2019 | Dec 2019 | NCT04238650 |
| MB02 | mAbxience | Avastin | Phase 1 | Comparative PK | Completed | Dec 2017 | May 2019 | NCT03293654 |
| MB02 | mAbxience | Avastin | Phase 3 | Comparative efficacy | Completed | Feb 2018 | Jul 2019 | NCT03296163 |
| MB02 | mAbxience | Avastin | Phase 1 | Comparative PK | Completed | Jan 2021 | Aug 2021 | NCT04408989 |
| BEVZ92 | mAbxience | Avastin | Phase 1 | Comparative PK | Completed | Oct 2014 | Oct 2015 | NCT02069704 |
| MB02 | mAbxience | Avastin | Phase 1 | Comparative PK | Completed | Sep 2019 | Mar 2020 | NCT04238663 |
Other developers in the same markets
Where Alymsys / Oyavas holds an approval, these are the other bevacizumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 5 | Amgen (Mvasi), Bio-Thera Solutions (Avzivi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Pfizer (Zirabev) |
| EMA | 6 | Amgen (Mvasi), Bio-Thera Solutions (Avzivi), Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Pfizer (Zirabev), Samsung Bioepis (Aybintio) |
| MHRA | 5 | Biocon Biologics (Jobevne / Abevmy / Krabeva), Celltrion (Vegzelma), Not stated in the MHRA list (Versavo), Pfizer (Zirabev), Samsung Bioepis (Aybintio) |
Same developer, other molecules
Other biosimilars in the Atlas developed by mAbxience: Boncresa / Oziltus / Denbrayce / Izamby.
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)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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