Biosimilars in India
Similar biologics with CDSCO manufacturing or import permissions, with firm, permission number and date from CDSCO's published lists; brands are not part of the CDSCO record.
Regulator: Central Drugs Standard Control Organisation
CDSCOproducts approved111
CDSCOmolecules with a biosimilar26
By molecule
Products approved per molecule.
Insulin glargine10Insulin human9Bevacizumab8Trastuzumab8Epoetin alfa and zeta7Rituximab7Denosumab6Pegfilgrastim6Ranibizumab6Adalimumab5Etanercept5Somatropin5Teriparatide4Darbepoetin alfa3Filgrastim3Follitropin alfa3Infliximab3Interferon alfa-2b3Pertuzumab3Aflibercept2Insulin aspart2Insulin lispro2Golimumab1Omalizumab1Tocilizumab1Ustekinumab1
Every record
| Molecule | Brand | Developer | Holder or applicant | Approved | Application or permission | Status |
|---|---|---|---|---|---|---|
| Adalimumab | Exemptia | Zydus Lifesciences | Cadila Healthcare Ltd | Sep 2014 | MF-222/2014 | Approved |
| Adalimumab | Reliance Life Sciences (INN only) | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | Jun 2015 | MF-150/2015 | Approved |
| Adalimumab | Mabura | Hetero | Hetero Drugs Limited | Jul 2017 | MF-124/2017 | Approved |
| Adalimumab | Enzene Biosciences (INN only) | Enzene Biosciences | Enzene Biosciences Ltd | Oct 2022 | MF/BIO/22/000100 | Approved |
| Adalimumab | Shilpa Biologicals (INN only) | Shilpa Biologicals | Shilpa Biologicals Pvt Ltd | Jun 2023 | MF/BIO/23/000057 | Approved |
| Adalimumab | Adfrar | Zydus Lifesciences | Torrent Pharmaceuticals | unverified | not published | Unverified |
| Aflibercept | Zydus Lifesciences (INN only) | Zydus Lifesciences | Zydus Lifesciences Limited | Jun 2025 | MF/BIO/25/000092 | Approved |
| Aflibercept | Yesafili | Biocon Biologics | Biocon Biologics Limited | Sep 2025 | IMP/BIO/25/000112 | Approved |
| Bevacizumab | Reliance Life Sciences (INN only) | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | Jan 2016 | MF-48/2016 | Approved |
| Bevacizumab | Hetero Drugs (INN only) | Hetero | Hetero Drugs Limited | May 2016 | MF-63/2016 | Approved |
| Bevacizumab | Intas Pharmaceuticals (INN only) | Intas Pharmaceuticals | Intas Pharmaceuticals Ltd | Jun 2016 | MF-65/2016 | Approved |
| Bevacizumab | Krabeva | Biocon Biologics | Biocon Limited | May 2017 | MF-90/2017 | Approved |
| Bevacizumab | Cadila Healthcare (INN only) | Zydus Lifesciences | Cadila Healthcare Ltd | May 2017 | MF-097/2017 | Approved |
| Bevacizumab | Dr. Reddy's Laboratories (INN only) | Dr. Reddy's Laboratories | Dr. Reddy's Laboratories Ltd | Sep 2018 | MF/BIO/18/000025 | Approved |
| Bevacizumab | Enzene Biosciences (INN only) | Enzene Biosciences | Enzene Biosciences Ltd | Feb 2023 | MF/BIO/23/000011 | Approved |
| Bevacizumab | CuraTeQ Biologics Private (INN only) | CuraTeQ Biologics | CuraTeQ Biologics Private Limited | May 2026 | MF/BIO/26/000060 | Approved |
| Darbepoetin alfa | Dr. Reddy's Laboratories (INN only) | Dr. Reddy's Laboratories | Dr. Reddy's Laboratories Ltd | Mar 2010 | MF-246/10 | Approved |
| Darbepoetin alfa | Hetero Drugs (INN only) | Hetero | Hetero Drugs Limited | Jan 2014 | MF-296/2013 | Approved |
| Darbepoetin alfa | Reliance Life Sciences (INN only) | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | Jun 2016 | MF-91/2016 | Approved |
| Denosumab | Intas Pharmaceuticals (INN only) | Intas Pharmaceuticals | Intas Pharmaceuticals Ltd | Jan 2018 | MF-284/2017 | Approved |
| Denosumab | Enzene Biosciences (INN only) | Enzene Biosciences | Enzene Biosciences Ltd | Jul 2021 | MF/BIO/21/000062 | Approved |
| Denosumab | Intas Pharmaceuticals (INN only) | Intas Pharmaceuticals | Intas Pharmaceuticals Ltd | Aug 2021 | MF/BIO/21/000083 | Approved |
| Denosumab | Reliance Life Sciences (INN only) | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | Dec 2022 | MF/BIO/22/000133 | Approved |
| Denosumab | Hetero Biopharma (INN only) | Hetero | Hetero Biopharma Limited | Dec 2024 | MF/BIO/24/000132 | Approved |
| Denosumab | Lupin (INN only) | Lupin | Lupin Limited | Jun 2026 | MF/BIO/26/000084 | Approved |
| Epoetin alfa and zeta | Biocon (INN only) | Not stated in the CDSCO list | Biocon Limited | Aug 2006 | Import permission | Approved |
| Epoetin alfa and zeta | Reliance Biopharmaceuticals (INN only) | Not stated in the CDSCO list | Reliance Biopharmaceuticals | Jan 2008 | Import permission | Approved |
| Epoetin alfa and zeta | Cadila Healthcare (INN only) | Zydus Lifesciences | Cadila Healthcare Ltd | Apr 2010 | MF-406/10 | Approved |
| Epoetin alfa and zeta | Bioviz Technologies (INN only) | Bioviz Technologies | Bioviz Technologies Pvt Ltd | Aug 2011 | MF-333/11 | Approved |
| Epoetin alfa and zeta | Lupin (INN only) | Not stated in the CDSCO list | Lupin Limited | Aug 2011 | Import permission | Approved |
| Epoetin alfa and zeta | Cipla (INN only) | Not stated in the CDSCO list | Cipla Limited | Nov 2021 | IMP/BIO/21/000096 | Approved |
| Epoetin alfa and zeta | Wockhardt (INN only) | Wockhardt | Wockhardt Limited | Feb 2023 | MF/BIO/23/000006 | Approved |
| Etanercept | Cipla (INN only) | Not stated in the CDSCO list | Cipla Limited | Oct 2012 | Import permission | Approved |
| Etanercept | Intas Pharmaceuticals (INN only) | Intas Pharmaceuticals | Intas Pharmaceuticals Ltd | Sep 2014 | MF-198/2014 | Approved |
| Etanercept | Reliance Life Sciences (INN only) | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | May 2018 | MF-124/2018 | Approved |
| Etanercept | Lupin (INN only) | Lupin | Lupin Limited | Mar 2019 | MF/BIO/19/000011 | Approved |
| Etanercept | Mylan Pharmaceuticals Private (INN only) | Lupin | Mylan Pharmaceuticals Private Limited, now Biocon Biologics Limited | Jan 2021 | MF/BIO/21/000005 | Approved |
| Filgrastim | Gennova Biopharmaceuticals (INN only) | Gennova Biopharmaceuticals | Gennova Biopharmaceuticals Ltd | Mar 2010 | MF-229/10 | Approved |
| Filgrastim | Lupin (INN only) | Lupin | Lupin Limited | Mar 2013 | MF-22/2013 | Approved |
| Filgrastim | Cadila Pharmaceuticals (INN only) | Cadila Pharmaceuticals | Cadila Pharmaceuticals Limited | Oct 2013 | MF-135/2013 | Approved |
| Follitropin alfa | Reliance Life Sciences (INN only) | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | Apr 2010 | MF-436/10 | Approved |
| Follitropin alfa | Intas Biopharmaceuticals (INN only) | Intas Pharmaceuticals | Intas Biopharmaceuticals Ltd | May 2013 | MF-99/2013 | Approved |
| Follitropin alfa | Cadila Healthcare (INN only) | Zydus Lifesciences | Cadila Healthcare Ltd | Jan 2018 | MF-208/2017 | Approved |
| Golimumab | Reliance Life Sciences (INN only) | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | Apr 2023 | MF/BIO/23/000038 | Approved |
| Infliximab | Reliance Life Sciences (INN only) | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | Mar 2014 | MF-61/2014 | Approved |
| Infliximab | Biocad India (INN only) | Biocad | Biocad India Pvt Ltd | Dec 2019 | Import permission | Approved |
| Infliximab | Pfizer (INN only) | Celltrion | Pfizer Limited | Sep 2021 | MP/BIO/21/000080 | Approved |
| Insulin aspart | Biogenomics (INN only) | Biogenomics | Biogenomics Limited | Oct 2021 | MF/BIO/21/000120 | Approved |
| Insulin aspart | Sanofi India (INN only) | Sanofi | Sanofi India Limited | May 2023 | IMP/BIO/23/000058 | Approved |
| Insulin glargine | Wockhardt (INN only) | Wockhardt | Wockhardt Limited | Feb 2007 | MF-7206/07 | Approved |
| Insulin glargine | LG Life Sciences (INN only) | LG Chem | LG Life Sciences | Dec 2011 | Import permission | Approved |
| Insulin glargine | Lupin (INN only) | Lupin | Lupin Limited | Feb 2015 | Import permission | Approved |
| Insulin glargine | Basaglar | Eli Lilly | Eli Lilly and Company (India) Pvt Ltd | Aug 2017 | Import permission | Approved |
| Insulin glargine | Biocon (INN only) | Biocon Biologics | Biocon Limited | Aug 2018 | Import permission | Approved |
| Insulin glargine | Cipla (INN only) | Cipla | Cipla Limited | Aug 2023 | IMP/BIO/23/000076 (additional marketing authorisation) | Approved |
| Insulin glargine | M.J. Biopharm (INN only) | M.J. Biopharm | M.J. Biopharm Pvt Ltd | Mar 2024 | MF/BIO/24/000037 | Approved |
| Insulin glargine | Regenix Biosciences (INN only) | Regenix | Regenix Biosciences Limited | Jun 2025 | MF/BIO/25/000096 | Approved |
| Insulin glargine | Eris Lifesciences (INN only) | Eris Lifesciences | Eris Lifesciences Limited; Eris Bionxt Private Limited | Dec 2025 | MF/BIO/25/000177 | Approved |
| Insulin glargine | Genesys Biologics (INN only) | Genesys Biologics | Genesys Biologics Pvt Ltd | Dec 2025 | MF/BIO/25/000186 | Approved |
| Insulin human | Gland Pharma (INN only) | Gland Pharma | Gland Pharma Ltd | Aug 2011 | MF-334/2011 | Approved |
| Insulin human | Shantha Biotechnics (INN only) | Sanofi | Shantha Biotechnics Limited | Nov 2013 | MF-243/2013 | Approved |
| Insulin human | Biocon (INN only) | Biocon Biologics | Biocon Limited | Feb 2018 | Import permission | Approved |
| Insulin human | MJ Biopharm (INN only) | M.J. Biopharm | MJ Biopharm Pvt Ltd | Jun 2018 | MF/BIO/18/000001 | Approved |
| Insulin human | Epygen Biotech Private (INN only) | Epygen Biotech | Epygen Biotech Private Limited | May 2021 | MF/BIO/21/000046 | Approved |
| Insulin human | Lupin (INN only) | Not stated in the CDSCO list | Lupin Limited | Jan 2024 | IMP/BIO/24/000008 (isophane) | Approved |
| Insulin human | Cadila Pharmaceuticals (INN only) | Cadila Pharmaceuticals | Cadila Pharmaceuticals Limited | Nov 2024 | MF/BIO/24/000126 | Approved |
| Insulin human | Eris Lifesciences (INN only) | Eris Lifesciences | Eris Lifesciences Limited; Eris Bionxt Private Limited | Dec 2025 | MF/BIO/25/000164 to MF/BIO/25/000182 (December 2025) | Approved |
| Insulin human | Regenix Drugs (INN only) | Regenix | Regenix Drugs Ltd | Apr 2026 | MF/BIO/26/000050 (biphasic) | Approved |
| Insulin lispro | Cipla (INN only) | Not stated in the CDSCO list | Cipla Limited | Sep 2021 | IMP/BIO/21/000084 (25/75 premix, September 2021) | Approved |
| Insulin lispro | Lupin (INN only) | Not stated in the CDSCO list | Lupin Limited | Apr 2024 | IMP/BIO/24/000038 | Approved |
| Interferon alfa-2b | USV (INN only) | Not stated in the CDSCO list | USV Ltd | Sep 2009 | Import permission | Approved |
| Interferon alfa-2b | Cadila Healthcare (INN only) | Zydus Lifesciences | Cadila Healthcare Ltd | Jun 2011 | MF-266/11 | Approved |
| Interferon alfa-2b | Intas Biopharmaceuticals (INN only) | Intas Pharmaceuticals | Intas Biopharmaceuticals Ltd | Apr 2013 | MF-89/2013 | Approved |
| Omalizumab | Reliance Life Sciences (INN only) | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | Feb 2020 | MF/BIO/20/000009 | Approved |
| Pegfilgrastim | Gennova Biopharmaceuticals (INN only) | Gennova Biopharmaceuticals | Gennova Biopharmaceuticals Ltd | Jan 2010 | MF-104/10 | Approved |
| Pegfilgrastim | Dr. Reddy's Laboratories (INN only) | Dr. Reddy's Laboratories | Dr. Reddy's Laboratories Ltd | Jan 2011 | MF-05/2011 | Approved |
| Pegfilgrastim | Lupin (INN only) | Lupin | Lupin Limited | Sep 2013 | MF-186/2013 | Approved |
| Pegfilgrastim | Wockhardt (INN only) | Wockhardt | Wockhardt Limited | Feb 2015 | MF-41/2015 | Approved |
| Pegfilgrastim | USV Private (INN only) | USV | USV Private Limited | Sep 2019 | MF/BIO/19/000044 | Approved |
| Pegfilgrastim | Virchow Biotech (INN only) | Virchow Biotech | Virchow Biotech Pvt Ltd | Dec 2021 | MF/BIO/21/000140 | Approved |
| Pertuzumab | Zydus Lifesciences (INN only) | Zydus Lifesciences | Zydus Lifesciences Limited | Apr 2024 | MF/BIO/24/000041 | Approved |
| Pertuzumab | Intas Pharmaceuticals (INN only) | Intas Pharmaceuticals | Intas Pharmaceuticals Ltd | Jan 2025 | MF/BIO/25/000006 | Approved |
| Pertuzumab | Enzene Biosciences (INN only) | Enzene Biosciences | Enzene Biosciences Ltd | Jun 2025 | MF/BIO/25/000085 | Approved |
| Ranibizumab | Razumab | Intas Pharmaceuticals | Intas Pharmaceuticals Ltd | Feb 2015 | MF-35/2015 | Approved |
| Ranibizumab | Reliance Life Sciences (INN only) | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | Mar 2020 | MF/BIO/20/000024 | Approved |
| Ranibizumab | Lupin (INN only) | Lupin | Lupin Limited | Oct 2021 | MF/BIO/21/000119 | Approved |
| Ranibizumab | Sun Pharmaceutical Industries (INN only) | Sun Pharmaceutical Industries | Sun Pharmaceutical Industries Limited | Mar 2023 | MF/BIO/23/000020 | Approved |
| Ranibizumab | Enzene Biosciences (INN only) | Enzene Biosciences | Enzene Biosciences Ltd | Aug 2023 | MF/BIO/23/000080 | Approved |
| Ranibizumab | Zenotech Laboratories (INN only) | Zenotech Laboratories | Zenotech Laboratories Limited | Oct 2023 | MF/BIO/23/000089 | Approved |
| Rituximab | Intas Pharmaceuticals (INN only) | Intas Pharmaceuticals | Intas Pharmaceuticals Ltd | Feb 2013 | MF-05/2013 | Approved |
| Rituximab | Zenotech Laboratories (INN only) | Zenotech Laboratories | Zenotech Laboratories Ltd | Feb 2013 | MF-36/2013 | Approved |
| Rituximab | Reliance Life Sciences (INN only) | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | Feb 2015 | MF-17/2015 | Approved |
| Rituximab | Hetero Drugs (INN only) | Hetero | Hetero Drugs Limited | Mar 2015 | MF-76/2015 | Approved |
| Rituximab | Biocad India (INN only) | Biocad | Biocad India Pvt Ltd | Jul 2017 | Import permission | Approved |
| Rituximab | Zydus Lifesciences (INN only) | Zydus Lifesciences | Zydus Lifesciences Limited | Jun 2025 | MF/BIO/25/000093 | Approved |
| Rituximab | Virchow Biotech Private (INN only) | Virchow Biotech | Virchow Biotech Private Limited | Aug 2025 | MF/BIO/25/000114 | Approved |
| Somatropin | L.G. Chemicals (LG Life Sciences) (INN only) | LG Chem | L.G. Chemicals (LG Life Sciences) | Aug 2002 | Import permission | Approved |
| Somatropin | SciGen Biopharma (INN only) | SciGen | SciGen Biopharma Pvt Ltd | Jun 2010 | Import permission | Approved |
| Somatropin | USV (INN only) | USV | USV Limited | Jun 2013 | MF-112/2013 | Approved |
| Somatropin | Reliance Life Sciences (INN only) | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | May 2018 | MF-145/2018 | Approved |
| Somatropin | Cipla (INN only) | Not stated in the CDSCO list | Cipla Limited | Oct 2020 | IMP/BIO/20/000082 (additional marketing authorisation) | Approved |
| Teriparatide | Intas Biopharmaceuticals (INN only) | Intas Pharmaceuticals | Intas Biopharmaceuticals Ltd | Nov 2010 | MF-893/10 | Approved |
| Teriparatide | USV (INN only) | USV | USV Limited | Aug 2012 | MF-179/2012 | Approved |
| Teriparatide | Cadila Healthcare (INN only) | Zydus Lifesciences | Cadila Healthcare Ltd | Aug 2012 | MF-207/2012 | Approved |
| Teriparatide | Enzene Biosciences (INN only) | Enzene Biosciences | Enzene Biosciences Limited | Jan 2021 | MF/BIO/21/000014 | Approved |
| Tocilizumab | Biopharma (INN only) | Firm name incomplete in the CDSCO list (Hyderabad) | Biopharma Limited, Hyderabad (name as printed in the CDSCO list) | Oct 2021 | MF/BIO/21/000104 | Approved |
| Trastuzumab | CANMAb | Biocon Biologics | Biocon Limited | Oct 2013 | MF-241/2013 | Approved |
| Trastuzumab | Reliance Life Sciences (INN only) | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | Jun 2015 | MF-120/2015 | Approved |
| Trastuzumab | Cadila Healthcare (INN only) | Zydus Lifesciences | Cadila Healthcare Ltd | Oct 2015 | MF-209/2015 | Approved |
| Trastuzumab | Dr. Reddy's Laboratories (INN only) | Dr. Reddy's Laboratories | Dr. Reddy's Laboratories Ltd | Mar 2018 | MF-69/2018 | Approved |
| Trastuzumab | Intas Pharmaceuticals (INN only) | Intas Pharmaceuticals | Intas Pharmaceuticals Ltd | Apr 2018 | MF-119/2018 | Approved |
| Trastuzumab | Biocad India (INN only) | Biocad | Biocad India Pvt Ltd | Apr 2018 | Import permission | Approved |
| Trastuzumab | CuraTeQ Biologics Private (INN only) | CuraTeQ Biologics | CuraTeQ Biologics Private Limited | Mar 2024 | MF/BIO/24/000036 | Approved |
| Trastuzumab | Biocon Biologics (INN only) | Biocon Biologics | Biocon Biologics Limited | Nov 2025 | MF/BIO/25/000156 | Approved |
| Ustekinumab | UstekiRel | Reliance Life Sciences | Reliance Life Sciences Pvt Ltd | Apr 2023 | MF/BIO/23/000037 | Approved |
Records checked against CDSCO's files, Sep 2026.
How CDSCO assesses a biosimilar
| Legal pathway | Guidelines on Similar Biologics (CDSCO and DBT, 2016, in force); revised draft published May 2025 |
|---|---|
| Reference product | Product licensed in India, or if not, one licensed in an ICH country, with justification |
| Comparative clinical study | Comparative PK/PD study and a comparative safety and efficacy study are generally expected, followed by a post-marketing study |
| Interchangeability | Not defined in the guidelines |
| Naming | INN with the brand name |
Sources: FDA draft guidance on comparative efficacy studies (October 2025) and interchangeability (June 2024); EMA reflection paper EMA/CHMP/BMWP/60916/2025 (March 2026) and EMA/HMA statement on interchangeability (September 2022); CDSCO Guidelines on Similar Biologics 2016 and 2025 draft (S009, S010); EDE directory (S018); MHLW/PMDA biosimilar guideline and notifications (S021); Health Canada guidance on biosimilar biologic drugs.
EvySaif prepares CDSCO submissions and regional dossier strategy for biosimilar developers. Regulatory strategy consulting
Sources
S011CDSCO, new drugs (r-DNA origin) approved for manufacture and marketing, Jan 2020 to June 2026 (CT-21) Primary (regulator)S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) Primary (regulator)S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)S014CDSCO, permissions granted in Form 46 and 46A, to 2019 Primary (regulator)S009CDSCO and DBT, Guidelines on Similar Biologics 2016 Primary (regulator)S010CDSCO, Draft Guidelines on Similar Biologics 2025 Primary (regulator)
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