Biocon Biologics
Biosimilar developer, India. 9 development products across 9 molecules: aflibercept, bevacizumab, denosumab, insulin aspart, insulin glargine, insulin human, pegfilgrastim, trastuzumab, ustekinumab.
First approval in the Atlas: Oct 2013, CANMAb, trastuzumab (CDSCO)
FDAproducts approved8
EMAproducts approved8
PMDAproducts approved1
HCproducts approved7
CDSCOproducts approved5
EDEproducts registered5
Portfolio by market
| Molecule | Product | FDA | EMA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Aflibercept | Yesafili MYL-1701P | May 2024 | Sep 2023 | · | Jun 2025 | Sep 2025 | · |
| Bevacizumab | Jobevne / Abevmy / Krabeva Bmab-100 | Apr 2025 | Apr 2021 | · | Nov 2021 | May 2017 | Feb 2022 |
| Denosumab | Bosaya / Aukelso / Vevzuo / Evfraxy Bmab 1000 | Sep 2025 | Jun 2025 | · | · | · | · |
| Insulin aspart | Kirsty MYL-1601D | Jul 2025 | Feb 2021 | · | Oct 2021 | · | Jul 2023 |
| Insulin glargine | Semglee MYL-1501D | Jul 2021 | Mar 2018 | Mar 2016 | Apr 2022 | Aug 2018 | Aug 2021 |
| Insulin human | Biocon human insulin | · | · | · | · | Feb 2018 | · |
| Pegfilgrastim | Fulphila / Vivlipeg / Biopegfil MYL-1401H | Jun 2018 | Nov 2018 | · | Dec 2018 | · | Feb 2019 |
| Trastuzumab | Ogivri / CANMAb MYL-1401O (Bmab-200) | Dec 2017 | Dec 2018 | · | May 2019 | Oct 2013 | Nov 2018 |
| Ustekinumab | Yesintek / Usrenty Bmab 1200 | Nov 2024 | Feb 2025 | · | Oct 2025 | · | · |
Month shown is the first approval or registration of that product in that market.
Also holds or markets
Products developed by another company for which Biocon Biologics is the licence holder or applicant in one or more markets.
| Molecule | Brand | Market | Holder or applicant | Approved | Developer |
|---|---|---|---|---|---|
| Adalimumab | Hulio | FDA | Biocon Biologics Inc. | Jul 2020 | Fujifilm Kyowa Kirin Biologics |
| Adalimumab | Hulio | HC | Biocon Biologics Canada INC | Nov 2020 | Fujifilm Kyowa Kirin Biologics |
| Adalimumab | Hulio | EDE | Terumo Yamaguchi Corporation for Biocon Biologics | May 2025 | Fujifilm Kyowa Kirin Biologics |
| Epoetin alfa and zeta | Biocon (INN only) | CDSCO | Biocon Limited | Aug 2006 | Not stated in the CDSCO list |
| Etanercept | Mylan Pharmaceuticals Private (INN only) | CDSCO | Mylan Pharmaceuticals Private Limited, now Biocon Biologics Limited | Jan 2021 | Lupin |
Chronology
- CDSCOOct 2013CANMAb, trastuzumab
- PMDAMar 2016Insulin Glargine BS FFP, insulin glargine
- CDSCOMay 2017Krabeva, bevacizumab
- FDADec 2017Ogivri, trastuzumab
- CDSCOFeb 2018Biocon (INN only), insulin human
- EMAMar 2018Semglee, insulin glargine
- FDAJun 2018Fulphila, pegfilgrastim
- CDSCOAug 2018Biocon (INN only), insulin glargine
- EDENov 2018Ogivri, trastuzumab
- EMANov 2018Fulphila, pegfilgrastim
- EMADec 2018Ogivri, trastuzumab
- HCDec 2018Fulphila, pegfilgrastim
- EDEFeb 2019Biopegfil, pegfilgrastim
- HCMay 2019Ogivri, trastuzumab
- EDENov 2019Fulphila, pegfilgrastim
- EMAFeb 2021Kirsty, insulin aspart
- EMAApr 2021Abevmy, bevacizumab
- FDAJul 2021Semglee, insulin glargine
- EDEAug 2021Semglee, insulin glargine
- HCOct 2021Kirsty, insulin aspart
- HCNov 2021Abevmy, bevacizumab
- EDEFeb 2022Abevmy, bevacizumab
- HCApr 2022Semglee, insulin glargine
- EDEJul 2023Kirsty, insulin aspart
- EMASep 2023Yesafili, aflibercept
- FDAMay 2024Yesafili, aflibercept
- FDANov 2024Yesintek, ustekinumab
- EMAFeb 2025Yesintek, ustekinumab
- FDAApr 2025Jobevne, bevacizumab
- EMAJun 2025Vevzuo, denosumab
- HCJun 2025Yesafili, aflibercept
- EMAJun 2025Evfraxy, denosumab
- FDAJul 2025Kirsty, insulin aspart
- EMAAug 2025Vivlipeg, pegfilgrastim
- FDASep 2025Aukelso, denosumab
- FDASep 2025Bosaya, denosumab
- EMASep 2025Usrenty, ustekinumab
- CDSCOSep 2025Yesafili, aflibercept
- HCOct 2025Yesintek, ustekinumab
- CDSCONov 2025Biocon Biologics (INN only), trastuzumab
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