Lupin
Biosimilar developer, India. 6 development products across 6 molecules: denosumab, etanercept, filgrastim, insulin glargine, pegfilgrastim, ranibizumab.
About Lupin
Lupin has six biosimilar molecules permitted in India and has taken two of them abroad. Its etanercept, permitted in India in 2019, is approved in Japan, Europe and Canada under four different names. Its ranibizumab, permitted in 2021, was approved in the United States and Europe in 2026, and its pegfilgrastim reached the United States in 2025 as Armlupeg. It also imports insulin glargine, insulin lispro and human insulin for India.
Portfolio by market
| Molecule | Product | FDA | EMA | MHRA | PMDA | HC | CDSCO | EDE | Markets |
|---|---|---|---|---|---|---|---|---|---|
| Denosumab | Lupin denosumab | · | · | · | · | · | Jun 2026 | · | 1/7 |
| Etanercept | Nepexto / Fubelv / Lupin etanercept YLB113 | · | May 2020 | MHRA | Mar 2019 | Aug 2022 | Mar 2019 | · | 5/7 |
| Filgrastim | Lupin filgrastim | · | · | · | · | · | Mar 2013 | · | 1/7 |
| Insulin glargine | Lupin insulin glargine | · | · | · | · | · | Feb 2015 | · | 1/7 |
| Pegfilgrastim | Armlupeg / Lupin pegfilgrastim | Nov 2025 | · | · | · | · | Sep 2013 | · | 2/7 |
| Ranibizumab | Ranluspec / Vislyfa | Jun 2026 | Feb 2026 | MHRA | · | · | Oct 2021 | · | 4/7 |
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 |
In development
ClinicalTrials.gov lists one comparative trial sponsored by Lupin for one molecule: ranibizumab. All of these candidates already have at least one approval in the seven markets.
| Molecule | Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | In the Atlas | Registry record |
|---|---|---|---|---|---|---|---|---|---|---|
| Ranibizumab | LUBT010 | Lupin | Lucentis | Phase 3 | Comparative efficacy | Completed | Sep 2020 | May 2024 | Ranluspec / Vislyfa | NCT04690556 |
Registry data from ClinicalTrials.gov, entered by the sponsors and not verified by any regulator. Status and dates are as posted; sponsors often update them late. Trials registered only on other registries, such as India's CTRI or China's ChiCTR, are not included. Checked 12 Sep 2026.
Companies on the same molecules
Developers whose portfolios overlap most with Lupin, by number of shared molecules. Overlap is the clearest sign of who competes with whom for the same tenders and licensing partners.
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
Compare Lupin with other developers on the comparison page.
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