Biosimilars in Japan
Biosimilars approved by MHLW on PMDA review, named under the Japanese convention of INN, BS and the holder's name, from PMDA's list of approved products.
Regulator: Pharmaceuticals and Medical Devices Agency and MHLW
PMDAproducts approved47
PMDAmolecules with a biosimilar23
By molecule
Products approved per molecule.
Adalimumab4Aflibercept4Bevacizumab4Ustekinumab4Darbepoetin alfa3Filgrastim3Infliximab3Trastuzumab3Etanercept2Insulin glargine2Rituximab2Tocilizumab2Agalsidase beta1Denosumab1Epoetin alfa and zeta1Golimumab1Insulin aspart1Insulin lispro1Omalizumab1Pegfilgrastim1Ranibizumab1Somatropin1Teriparatide1
Every record
| Molecule | Brand | Developer | Holder or applicant | Approved | Application or permission | Status |
|---|---|---|---|---|---|---|
| Adalimumab | Adalimumab BS FKB | Fujifilm Kyowa Kirin Biologics | Fujifilm Kyowa Kirin Biologics | Jun 2020 | not published | Approved |
| Adalimumab | Adalimumab BS Daiichi Sankyo | Daiichi Sankyo | Daiichi Sankyo | Jan 2021 | not published | Approved |
| Adalimumab | Adalimumab BS MA | Mochida Pharmaceutical | Mochida Pharmaceutical | Mar 2021 | not published | Approved |
| Adalimumab | Adalimumab BS CTNK | Celltrion | Nippon Kayaku (Celltrion) | Sep 2023 | not published | Approved |
| Aflibercept | Aflibercept BS GRP | Global Regulatory Partners | Global Regulatory Partners | Jun 2024 | not published | Approved |
| Aflibercept | Aflibercept BS NIT | Fuji Pharma | Fuji Pharma | Sep 2025 | not published | Approved |
| Aflibercept | Aflibercept BS SCD | Sam Chun Dang Pharm | SamChunDang Pharm | Sep 2025 | not published | Approved |
| Aflibercept | Aflibercept BS CT | Celltrion | Celltrion Healthcare Japan | Mar 2026 | not published | Approved |
| Agalsidase beta | Agalsidase Beta BS [JCR] | JCR Pharmaceuticals | JCR Pharmaceuticals | Sep 2018 | not published | Approved |
| Bevacizumab | Bevacizumab BS [Pfizer] | Pfizer | Pfizer Japan | Jun 2019 | not published | Approved |
| Bevacizumab | Bevacizumab BS Amgen | Amgen | Amgen K.K. | Sep 2019 | not published | Approved |
| Bevacizumab | Bevacizumab BS Nichi-Iko | Nichi-Iko Pharmaceutical | Nichi-Iko Pharmaceutical | Jan 2022 | not published | Approved |
| Bevacizumab | Bevacizumab BS CTNK | Celltrion | Nippon Kayaku (Celltrion) | Sep 2022 | not published | Approved |
| Darbepoetin alfa | Darbepoetin Alfa BS [JCR] | JCR Pharmaceuticals | JCR Pharmaceuticals | Sep 2019 | not published | Approved |
| Darbepoetin alfa | Darbepoetin Alfa BS Sanwa | Sanwa Kagaku Kenkyusho | Sanwa Kagaku Kenkyusho | Sep 2019 | not published | Approved |
| Darbepoetin alfa | Darbepoetin Alfa BS MYL | Viatris | Mylan | Sep 2019 | not published | Approved |
| Denosumab | Denosumab BS 120 mg RM F | Fuji Pharma | Fuji Pharma | Sep 2025 | not published | Approved |
| Epoetin alfa and zeta | Epoetin Alfa BS [JCR] | JCR Pharmaceuticals | JCR Pharmaceuticals | Jan 2010 | not published | Approved |
| Etanercept | Etanercept BS MA | Mochida Pharmaceutical | Mochida Pharmaceutical | Jan 2018 | not published | Approved |
| Etanercept | Etanercept BS TY / Nichiiko | Lupin | Yoshindo; Nichi-Iko Pharmaceutical | Mar 2019 | not published | Approved |
| Filgrastim | Filgrastim BS F / Mochida | Fuji Pharma | Fuji Pharma; Mochida Pharmaceutical | Nov 2012 | not published | Approved |
| Filgrastim | Filgrastim BS NK | Nippon Kayaku | Nippon Kayaku | Feb 2013 | not published | Approved |
| Filgrastim | Filgrastim BS Sandoz | Sandoz | Sandoz K.K. | Mar 2014 | not published | Approved |
| Golimumab | Golimumab BS F | Fuji Pharma | Fuji Pharma | Sep 2025 | not published | Approved |
| Infliximab | Infliximab BS NK | Celltrion | Celltrion Healthcare Japan (marketed by Nippon Kayaku) | Jul 2014 | not published | Approved |
| Infliximab | Infliximab BS Nichiiko / AYUMI | Nichi-Iko Pharmaceutical | Nichi-Iko Pharmaceutical; Ayumi Pharmaceutical | Sep 2017 | not published | Approved |
| Infliximab | Infliximab BS [Pfizer] | Pfizer | Pfizer Japan | Jul 2018 | not published | Approved |
| Insulin aspart | Insulin Aspart BS NR Sanofi | Sanofi | Sanofi K.K. | Mar 2021 | not published | Approved |
| Insulin glargine | Insulin Glargine BS [Lilly] | Eli Lilly | Eli Lilly Japan | Dec 2014 | not published | Approved |
| Insulin glargine | Insulin Glargine BS FFP | Biocon Biologics | Fujifilm Pharma (Biocon product) | Mar 2016 | not published | Approved |
| Insulin lispro | Insulin Lispro BS HU Sanofi | Sanofi | Sanofi K.K. | Mar 2020 | not published | Approved |
| Omalizumab | Omalizumab BS CT | Celltrion | Celltrion Healthcare Japan | Mar 2026 | not published | Approved |
| Pegfilgrastim | Pegfilgrastim BS Mochida / Nipro | Mochida Pharmaceutical | Mochida Pharmaceutical; Mochida Pharmaceutical Sales | Sep 2023 | not published | Approved |
| Ranibizumab | Ranibizumab BS Senju | Senju Pharmaceutical | Senju Pharmaceutical | Sep 2021 | not published | Approved |
| Rituximab | Rituximab BS [KHK] | Sandoz | Sandoz K.K. (co-developed with Kyowa Kirin) | Sep 2017 | not published | Approved |
| Rituximab | Rituximab BS [Pfizer] | Pfizer | Pfizer Japan | Sep 2019 | not published | Approved |
| Somatropin | Somatropin BS [Sandoz] | Sandoz | Sandoz K.K. | Jun 2009 | not published | Approved |
| Teriparatide | Teriparatide BS MOCHIDA | Mochida Pharmaceutical | Mochida Pharmaceutical | Sep 2019 | not published | Approved |
| Tocilizumab | Tocilizumab BS CT | Celltrion | Celltrion Healthcare Japan | Sep 2025 | not published | Approved |
| Tocilizumab | Tocilizumab BS MA | Mochida Pharmaceutical | Mochida Pharmaceutical | Mar 2026 | not published | Approved |
| Trastuzumab | Trastuzumab BS NK | Celltrion | Celltrion Healthcare Japan (marketed by Nippon Kayaku) | Mar 2018 | not published | Approved |
| Trastuzumab | Trastuzumab BS Daiichi Sankyo | Amgen | Daiichi Sankyo | Sep 2018 | not published | Approved |
| Trastuzumab | Trastuzumab BS [Pfizer] | Pfizer | Pfizer Japan | Sep 2018 | not published | Approved |
| Ustekinumab | Ustekinumab BS F | Fuji Pharma | Fuji Pharma | Sep 2023 | not published | Approved |
| Ustekinumab | Ustekinumab BS YD | Yoshindo | Yoshindo | Dec 2024 | not published | Approved |
| Ustekinumab | Ustekinumab BS CT | Celltrion | Celltrion Healthcare Japan | Mar 2025 | not published | Approved |
| Ustekinumab | Ustekinumab BS Nipro | Nipro | Nipro | Dec 2025 | not published | Approved |
Records checked against PMDA's files, Sep 2026.
How PMDA assesses a biosimilar
| Legal pathway | MHLW approval on PMDA review under the Guideline for Ensuring Quality, Safety and Efficacy of Biosimilars (2009, revised 2020), with Q&A updates in 2024 and 2026 |
|---|---|
| Reference product | The original biopharmaceutical approved in Japan; foreign-sourced reference accepted with bridging since the 2020 revision |
| Comparative clinical study | Comparative PK study and, in principle, a comparative efficacy study; the May 2026 early consideration sets out when the efficacy study can be omitted, and Japanese patient data are no longer required in every case (2025) |
| Interchangeability | Not defined; prescribing by brand, with pharmacist substitution not automatic |
| Naming | INN followed by BS (biosimilar), strength, form and the company name in quotation marks, with a biosimilar number in the non-proprietary 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.
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Sources
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