Lupin
Biosimilar developer, India. 6 development products across 6 molecules: denosumab, etanercept, filgrastim, insulin glargine, pegfilgrastim, ranibizumab.
First approval in the Atlas: Mar 2013, Lupin (INN only), filgrastim (CDSCO)
FDAproducts approved2
EMAproducts approved2
PMDAproducts approved1
HCproducts approved1
CDSCOproducts approved6
EDEproducts registered0
Portfolio by market
| Molecule | Product | FDA | EMA | PMDA | HC | CDSCO | EDE |
|---|---|---|---|---|---|---|---|
| Denosumab | Lupin denosumab | · | · | · | · | Jun 2026 | · |
| Etanercept | Nepexto / Fubelv / Lupin etanercept YLB113 | · | May 2020 | Mar 2019 | Aug 2022 | Mar 2019 | · |
| Filgrastim | Lupin filgrastim | · | · | · | · | Mar 2013 | · |
| Insulin glargine | Lupin insulin glargine | · | · | · | · | Feb 2015 | · |
| Pegfilgrastim | Armlupeg / Lupin pegfilgrastim | Nov 2025 | · | · | · | Sep 2013 | · |
| Ranibizumab | Ranluspec / Vislyfa | Jun 2026 | Feb 2026 | · | · | Oct 2021 | · |
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 Lupin is the licence holder or applicant in one or more markets.
| Molecule | Brand | Market | Holder or applicant | Approved | Developer |
|---|---|---|---|---|---|
| Epoetin alfa and zeta | Lupin (INN only) | CDSCO | Lupin Limited | Aug 2011 | Not stated in the CDSCO list |
| Insulin human | Lupin (INN only) | CDSCO | Lupin Limited | Jan 2024 | Not stated in the CDSCO list |
| Insulin lispro | Lupin (INN only) | CDSCO | Lupin Limited | Apr 2024 | Not stated in the CDSCO list |
Chronology
- CDSCOMar 2013Lupin (INN only), filgrastim
- CDSCOSep 2013Lupin (INN only), pegfilgrastim
- CDSCOFeb 2015Lupin (INN only), insulin glargine
- CDSCOMar 2019Lupin (INN only), etanercept
- PMDAMar 2019Etanercept BS TY / Nichiiko, etanercept
- EMAMay 2020Nepexto, etanercept
- CDSCOJan 2021Mylan Pharmaceuticals Private (INN only), etanercept
- CDSCOOct 2021Lupin (INN only), ranibizumab
- HCAug 2022Rymti, etanercept
- FDANov 2025Armlupeg, pegfilgrastim
- EMAFeb 2026Ranluspec, ranibizumab
- EMAApr 2026Fubelv, etanercept
- FDAJun 2026Ranluspec, ranibizumab
- CDSCOJun 2026Lupin (INN only), denosumab
- EMAJul 2026Vislyfa, ranibizumab
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