Japan · biosimilars · バイオ後続品 · NHI prices · uptake
Every biosimilar approved in Japan, by molecule: who sells it, when it was approved, listed and launched, its NHI price versus the originator, and how far it has replaced the originator. Plus Japan's 2029 target and the biologics with no biosimilar yet.
Last updated: 2026-09-28 · PMDA biosimilar list as of 2026-09 · sources: PMDA, MHLW (PDL1.0), company releases; processed and translated
Target: by the end of FY2029 (March 2030), biosimilars should hold ≥80% of volume in ≥60% of the molecules that have a biosimilar (set by the Medical Insurance Committee on 14 Mar 2024 and restated in MHLW's biosimilar policy of 30 Sep 2024; to be reviewed around the end of FY2026). Source.
Progress: FY2024 22.2% — far from 60%. Official figures come from MHLW's price survey; our own calculation from NDB open data finds the same four molecules above 80% (4 of the 18 molecules we could compute).
| Fiscal year | Value | What it measures | Source |
|---|---|---|---|
| FY2024 | 22.2% | Official figure (MHLW drug price survey): molecules where biosimilars have ≥80% of volume, out of all molecules with a biosimilar | MHLW, Social Security Council Medical Insurance Committee, 6 Nov 2025, p.22 |
| FY2024 | 33.7% | Biosimilar share by value (2024 price survey) — a reference figure, not the target metric | Chuikyo General Assembly, 5 Dec 2025, p.21 |
| FY2024 | 22.2% | Our own calculation from the 11th NDB open data: 4 of 18 molecules at ≥80% (epoetin alfa, filgrastim, rituximab, trastuzumab). Not an official figure | MHLW NDB open data (11th release) |
| FY2022 | 12.5% | NDB open data (standard-unit volume): 2 molecules at ≥80%; we divide by the 16 molecules shown in the same report | MHLW-commissioned biosimilar survey (Mitsubishi UFJ Research & Consulting), Mar 2025, p.185 |
Japan has approved 49 biosimilars (designations) for 23 reference biologics; 112 biosimilar products (by strength) are on the NHI price list, sold by 19 companies (PMDA list as of 2026-09). At the same NHI strength, the median biosimilar list price is 62% of the originator (97 pairs; range 35%–132%). MHLW puts the FY2024 biosimilar market at about ¥86.6 billion, with biosimilars at 33.7% of their molecules' value and only 22.2% of molecules reaching the 80% volume goal (MHLW, 6 Nov 2025; Chuikyo, 5 Dec 2025). We do not repeat private market-size forecasts.
The companies selling the most biosimilar molecules on the NHI list are Celltrion Healthcare Japan (6), Fuji Pharma (5), Mochida Pharmaceutical (5), Pfizer Japan (4), Daiichi Sankyo (3), JCR Pharmaceuticals (3). Foreign developers usually partner with a Japanese marketing company: Celltrion (Adalimumab, Aflibercept, Bevacizumab, Infliximab); Alvotech (Aflibercept, Denosumab, Golimumab, Ustekinumab); Gedeon Richter (Tocilizumab); SamChunDang Pharm. (Aflibercept); Samsung Bioepis (Ustekinumab). Full company list ↓
Yes, but only for Ranmark (120 mg, bone metastases). Fuji Pharma's denosumab BS 120 mg “F” (developer: Alvotech) was approved on 2025-09-19 and NHI-listed on 2026-05-20 at 55% of Ranmark's price (same strength). No biosimilar of Pralia (Prolia) 60 mg for osteoporosis is approved in Japan (PMDA list as of 2026-09), and Ranmark's 120 mg prefilled syringe has no biosimilar strength. Denosumab page →
Yes. 4 Eylea 2 mg biosimilar designations are approved (2024-06-24 to 2026-03-23): Global Regulatory Partners 2024-06-24, SamChunDang Pharm. 2025-09-19, Fuji Pharma (Alvotech) 2025-09-19, Celltrion Healthcare Japan 2026-03-23. Only Fuji Pharma's “NIT” product (developer Alvotech) is NHI-listed (2025-11-12, 68% of Eylea at the same strength). Fuji started sales on 7 January 2026 excluding diabetic macular edema; under its settlement with Regeneron/Bayer it may sell for all approved indications from 1 November 2026 (Fuji Pharma release). Eylea 8 mg has no biosimilar. Bayer also lists an authorised biologic (bio-AG) of the 2 mg kit. Aflibercept page →
Japan has no separate biologics data-exclusivity term. Protection comes from the re-examination period under the PMD Act: usually 8 years for a new active ingredient, up to 10 years for orphan drugs (and some extensions). A biosimilar can be filed only after the reference product's re-examination period ends. Separately, a patent can get a patent term extension (PTE) of up to 5 years for time lost to regulatory review, and under patent linkage MHLW does not approve a biosimilar while a relevant substance patent is in force. After approval, biosimilars have been added to the NHI list in May and November (e.g. 12 Nov 2025, 20 May 2026). Which biologics are next ↓ · Generic entry calendar
Every reference biologic with a Japanese biosimilar approval. Click a column to sort. Ingredients in blue have their own page. Download: aggregates by ingredient (CSV, UTF-8).
| Ingredient | Originator | BS approvals | Listed BS products | Companies (developer) | First BS listed | Median price ratio | BS volume share FY2024 |
|---|---|---|---|---|---|---|---|
| Ustekinumab ウステキヌマブ(遺伝子組換え) | Stelara ヤンセンファーマ | 5 | 6 | Fuji Pharma (Alvotech); Yoshindo; Celltrion Healthcare Japan; Nipro (Samsung Bioepis); Meiji Seika Pharma; Yoshindo Holdings | 2024-05-22 | 68% | 0.5% own calc. |
| Adalimumab アダリムマブ(遺伝子組換え) | Humira アッヴィ | 4 | 15 | Fujifilm Kyowa Kirin Biologics; Daiichi Sankyo; Mochida Pharmaceutical; Nippon Kayaku (Celltrion) | 2020-11-25 | 42% | 26.6% own calc. |
| Aflibercept アフリベルセプト(遺伝子組換え) | Eylea バイエル薬品 | 4 | 2 | Global Regulatory Partners; SamChunDang Pharm.; Fuji Pharma (Alvotech); Celltrion Healthcare Japan | 2025-11-12 | 68% | listed after FY2024 |
| Bevacizumab ベバシズマブ(遺伝子組換え) | Avastin 中外製薬 | 4 | 6 | Pfizer Japan; Daiichi Sankyo; Nichi-Iko Pharmaceutical; Nippon Kayaku (Celltrion) | 2019-11-27 | 40% | 56.1% own calc. |
| Darbepoetin alfa ダルベポエチンアルファ(遺伝子組換え) | Nesp 協和キリン | 3 | 18 | Mylan EPD; Sanwa Kagaku Kenkyusho; JCR Pharmaceuticals | 2019-11-27 | 59% | 67.0% own calc. |
| Filgrastim フィルグラスチム(遺伝子組換え) | Gran 協和キリン | 3 | 6 | Fuji Pharma; Teva Pharma Japan; Sandoz; Nippon Kayaku | by Dec 2015 | 58% | 95.2% own calc. |
| Infliximab インフリキシマブ(遺伝子組換え) | Remicade 田辺ファーマ | 3 | 4 | Celltrion; Yakuhan Pharmaceutical; Pfizer Japan; Celltrion Healthcare Japan; Ayumi Pharmaceutical; Nichi-Iko Pharmaceutical | by Dec 2015 | 39% | 41.3% own calc. |
| Trastuzumab トラスツズマブ(遺伝子組換え) | Herceptin 中外製薬 | 3 | 4 | Celltrion; Pfizer Japan; Daiichi Sankyo; Celltrion Healthcare Japan | 2018-05-30 | 41% | 80.1% own calc. |
| Etanercept エタネルセプト(遺伝子組換え) | Enbrel ファイザー | 2 | 14 | Mochida Pharmaceutical; Kyowa Pharmaceutical Industry; Yoshindo Holdings; Nichi-Iko Pharmaceutical | 2018-05-30 | 68% | 60.3% own calc. |
| Insulin glargine インスリングラルギン(遺伝子組換え) | Lantus サノフィ | 2 | 3 | Eli Lilly Japan; (Fujifilm Pharma Co., Ltd.); Fujifilm Toyama Chemical | by Dec 2015 | 109% | 78.6% own calc. |
| Pegfilgrastim ペグフィルグラスチム(遺伝子組換え) | G-Lasta 協和キリン | 2 | 2 | [1] Mochida Pharmaceutical Co., Ltd. [2] Mochida Pharmaceutical Sales; Global Regulatory Partners; Mochida Pharmaceutical Sales; Mochida Pharmaceutical | 2023-11-22 | 71% | 28.3% own calc. |
| Rituximab リツキシマブ(遺伝子組換え) | Rituxan 全薬工業 | 2 | 4 | Sandoz; Pfizer Japan | 2017-11-29 | 56% | 82.7% own calc. |
| Tocilizumab トシリズマブ(遺伝子組換え) | Actemra 中外製薬 | 2 | 6 | Celltrion Healthcare Japan; Mochida Pharmaceutical (Gedeon Richter) | 2025-11-12 | 67% | listed after FY2024 |
| Agalsidase beta アガルシダーゼベータ(遺伝子組換え) | Fabrazyme サノフィ | 1 | 2 | JCR Pharmaceuticals | 2018-11-28 | 73% | 30.5% own calc. |
| Denosumab デノスマブ(遺伝子組換え) | Ranmark 第一三共 | 1 | 1 | Fuji Pharma (Alvotech) | 2026-05-20 | 55% | listed after FY2024 |
| Epoetin alfa エポエチンアルファ(遺伝子組換え) biosimilar INN differs from the reference (epoetin kappa vs epoetin alfa) | Espo 協和キリン | 1 | 4 | JCR Pharmaceuticals | by Dec 2015 | – | 91.8% own calc. |
| Golimumab ゴリムマブ(遺伝子組換え) | Simponi ヤンセンファーマ | 1 | 1 | Fuji Pharma (Alvotech) | 2026-05-20 | 62% | listed after FY2024 |
| Insulin aspart インスリンアスパルト(遺伝子組換え) | NovoRapid ノボ ノルディスク ファーマ | 1 | 3 | Sanofi | 2021-05-26 | 115% | 25.9% own calc. |
| Insulin lispro インスリンリスプロ(遺伝子組換え) | Humalog 日本イーライリリー | 1 | 3 | Sanofi | 2020-05-27 | 56% | 30.0% own calc. |
| Omalizumab オマリズマブ(遺伝子組換え) | Xolair ノバルティス ファーマ | 1 | 4 | Celltrion Healthcare Japan | 2026-05-20 | 69% | listed after FY2024 |
| Ranibizumab ラニビズマブ(遺伝子組換え) | Lucentis ノバルティス ファーマ | 1 | 1 | Senju Pharmaceutical | 2021-11-25 | 78% | 70.8% own calc. |
| Somatropin ソマトロピン(遺伝子組換え) | Genotropin JCRファーマ, ノボ ノルディスク ファーマ, ファイザー | 1 | 2 | Sandoz | by Dec 2015 | – | 42.9% own calc. |
| Teriparatide テリパラチド(遺伝子組換え) | Forteo 日本イーライリリー | 1 | 1 | Mochida Pharmaceutical | 2019-11-27 | 74% | 74.5% own calc. |
BS approvals = PMDA biosimilar designations ([… biosimilar N]). Listed BS products = NHI price-list entries (each strength counts). Companies = PMDA applicant or NHI marketing company, with the verified developer in brackets. Median price ratio = biosimilar NHI price ÷ originator NHI price at the identical NHI strength. own calc. = our own calculation from MHLW NDB open data (FY2024 = April 2024–March 2025; volume converted to active ingredient; biosimilar ÷ biosimilar + reference product; DPC-bundled inpatient use is not in the NDB, and cells under 400 are hidden and counted as 0). Not an official figure.
Last 12 months (2025-09-28 to 2026-09-28), newest first. Only events confirmed on the PMDA / MHLW lists or in the company's own release; press-only reports are left out.
| Date | Event | Ingredient | Company | Details | Source |
|---|---|---|---|---|---|
| 2026-09-16 | Approval | Ustekinumab | Meiji Seika Pharma | [ustekinumab biosimilar 5] | [source] |
| 2026-09-02 | Approval | Ustekinumab | Nipro (developer: Samsung Bioepis) | [ustekinumab biosimilar 4] ウステキヌマブBS点滴静注130mg「ニプロ」 Approval of the IV 130 mg form (2nd product under the Nipro-Samsung Bioepis partnership). Company plans NHI listing and launch in Nov 2026. (Release dated 3 Sep 2026; approval dated 2 Sep 2026.) | [source] |
| 2026-08-24 | Approval | Pegfilgrastim | Global Regulatory Partners | [pegfilgrastim biosimilar 2] | [source] |
| 2026-08-20 | Launch | Ustekinumab | Celltrion Healthcare Japan | [ustekinumab biosimilar 3] ウステキヌマブBS点滴静注130mg「CT」 Launch of the IV 130 mg form (Crohn's disease induction). Launch date 20 Aug 2026 per the company notice. | [source] |
| 2026-05-20 | NHI listing | Ustekinumab | Fuji Pharma (developer: Alvotech) | [ustekinumab biosimilar 1] ウステキヌマブBS皮下注90mgシリンジ「F」 | [source] |
| 2026-05-20 | NHI listing | Ustekinumab | Celltrion Healthcare Japan | [ustekinumab biosimilar 3] ウステキヌマブBS点滴静注130mg「CT」 55% of originator | [source] |
| 2026-05-20 | NHI listing | Ustekinumab | Nipro (developer: Samsung Bioepis) | [ustekinumab biosimilar 4] ウステキヌマブBS皮下注45mgシリンジ「ニプロ」 68% of originator | [source] |
| 2026-05-20 | NHI listing | Omalizumab | Celltrion Healthcare Japan | [omalizumab biosimilar 1] オマリズマブBS皮下注75mgシリンジ「CT」, オマリズマブBS皮下注150mgシリンジ「CT」, オマリズマブBS皮下注75mgペン「CT」… 69%–70% of originator | [source] |
| 2026-05-20 | NHI listing | Golimumab | Fuji Pharma (developer: Alvotech) | [golimumab biosimilar 1] ゴリムマブBS皮下注50mgシリンジ「F」 62% of originator NHI listing after an agreement with Janssen Biotech and Alvotech (4 Nov 2025). | [source 1] [source 2] |
| 2026-05-20 | NHI listing | Denosumab | Fuji Pharma (developer: Alvotech) | [denosumab biosimilar 1] デノスマブBS皮下注120mgRM「F」 55% of originator | [source] |
| 2026-05-20 | NHI listing | Tocilizumab | Mochida Pharmaceutical (developer: Gedeon Richter) | [tocilizumab biosimilar 2] トシリズマブBS点滴静注80mg「MA」, トシリズマブBS点滴静注200mg「MA」, トシリズマブBS点滴静注400mg「MA」 66%–72% of originator | [source] |
| 2026-05-20 | Launch | Ustekinumab | Nipro (developer: Samsung Bioepis) | [ustekinumab biosimilar 4] ウステキヌマブBS皮下注45mgシリンジ「ニプロ」 Launch on the day the NHI listing took effect (20 May 2026), per the company release of 19 May 2026. | [source] |
| 2026-04-28 | Launch | Tocilizumab | Celltrion Healthcare Japan | [tocilizumab biosimilar 1] トシリズマブBS点滴静注80mg「CT」, トシリズマブBS点滴静注200mg「CT」, トシリズマブBS点滴静注400mg「CT」 Launch (first Actemra biosimilar on the Japanese market). Launch date 28 Apr 2026 per the company notice. | [source] |
| 2026-03-23 | Approval | Aflibercept | Celltrion Healthcare Japan | [aflibercept biosimilar 4] | [source] |
| 2026-03-23 | Approval | Omalizumab | Celltrion Healthcare Japan | [omalizumab biosimilar 1] | [source] |
| 2026-03-23 | Approval | Tocilizumab | Mochida Pharmaceutical (developer: Gedeon Richter) | [tocilizumab biosimilar 2] トシリズマブBS点滴静注80mg「MA」, トシリズマブBS点滴静注200mg「MA」, トシリズマブBS点滴静注400mg「MA」… Approval of RGB-19 (Mochida / Gedeon Richter). Mochida supplies, Ayumi Pharmaceutical sells. | [source 1] [source 2] |
| 2026-01-07 | Launch | Aflibercept | Fuji Pharma / Nittoh Medic (developer: Alvotech) | [aflibercept biosimilar 2] アフリベルセプトBS硝子体内注射液40mg/mL「NIT」, アフリベルセプトBS硝子体内注射用キット40mg/mL「NIT」 Sales started 7 Jan 2026 (excluding diabetic macular edema). Under the Alvotech-Regeneron-Bayer settlement, all approved indications from 1 Nov 2026. | [source] |
| 2025-12-22 | Approval | Ustekinumab | Nipro (developer: Samsung Bioepis) | [ustekinumab biosimilar 4] | [source] |
| 2025-11-12 | NHI listing | Aflibercept | Fuji Pharma (developer: Alvotech) | [aflibercept biosimilar 2] アフリベルセプトBS硝子体内注射液40mg/mL「NIT」, アフリベルセプトBS硝子体内注射用キット40mg/mL「NIT」 68% of originator | [source] |
| 2025-11-12 | NHI listing | Tocilizumab | Celltrion Healthcare Japan | [tocilizumab biosimilar 1] トシリズマブBS点滴静注80mg「CT」, トシリズマブBS点滴静注200mg「CT」, トシリズマブBS点滴静注400mg「CT」 66%–72% of originator Listed on the NHI price list 12 Nov 2025 (IV 80/200/400 mg). | [source 1] [source 2] |
| Date | Event | Ingredient | Company | Details | Source |
|---|---|---|---|---|---|
| 2026-11-01 | Licence / settlement | Aflibercept | Fuji Pharma / Nittoh Medic (developer: Alvotech) | [aflibercept biosimilar 2] Scheduled: sales for all approved indications (settlement with Regeneron/Bayer). | [source] |
Marketing companies (NHI list), applicants (PMDA list) and developers confirmed in an official release. A developer is shown only when we could verify it; many Japanese marketers do not name theirs.
| Company | Role | Designations | Ingredients |
|---|---|---|---|
| Celltrion | developer (KR) | 8 | Adalimumab, Aflibercept, Bevacizumab, Infliximab, Omalizumab, Tocilizumab, Trastuzumab, Ustekinumab |
| Celltrion Healthcare Japan セルトリオン・ヘルスケア・ジャパン | applicant (PMDA), marketing (NHI list) | 6 | Aflibercept, Infliximab, Omalizumab, Tocilizumab, Trastuzumab, Ustekinumab |
| Fuji Pharma 富士製薬工業 | marketing (NHI list) | 5 | Aflibercept, Denosumab, Filgrastim, Golimumab, Ustekinumab |
| Mochida Pharmaceutical 持田製薬 | marketing (NHI list) | 5 | Adalimumab, Etanercept, Pegfilgrastim, Teriparatide, Tocilizumab |
| Alvotech | developer (IS) | 4 | Aflibercept, Denosumab, Golimumab, Ustekinumab |
| Pfizer Japan ファイザー | marketing (NHI list) | 4 | Bevacizumab, Infliximab, Rituximab, Trastuzumab |
| Daiichi Sankyo 第一三共 | applicant (PMDA), marketing (NHI list) | 3 | Adalimumab, Bevacizumab, Trastuzumab |
| JCR Pharmaceuticals JCRファーマ | marketing (NHI list) | 3 | Agalsidase beta, Darbepoetin alfa, Epoetin alfa |
| Nichi-Iko Pharmaceutical 日医工 | marketing (NHI list) | 3 | Bevacizumab, Etanercept, Infliximab |
| Nippon Kayaku 日本化薬 | marketing (NHI list) | 3 | Adalimumab, Bevacizumab, Filgrastim |
| Sandoz サンド | applicant (PMDA), marketing (NHI list) | 3 | Filgrastim, Rituximab, Somatropin |
| Global Regulatory Partners | applicant (PMDA) | 2 | Aflibercept, Pegfilgrastim |
| Sanofi サノフィ | marketing (NHI list) | 2 | Insulin aspart, Insulin lispro |
| Yoshindo Holdings 陽進堂ホールディングス | marketing (NHI list) | 2 | Etanercept, Ustekinumab |
| Ayumi Pharmaceutical あゆみ製薬 | marketing (NHI list) | 1 | Infliximab |
| Eli Lilly Japan 日本イーライリリー | marketing (NHI list) | 1 | Insulin glargine |
| Fujifilm Kyowa Kirin Biologics 協和キリン富士フイルムバイオロジクス | marketing (NHI list) | 1 | Adalimumab |
| Fujifilm Toyama Chemical 富士フイルム富山化学 | marketing (NHI list) | 1 | Insulin glargine |
| Gedeon Richter (co-developed with Mochida, RGB-19) | developer (JP/HU) | 1 | Tocilizumab |
| Meiji Seika Pharma | applicant (PMDA) | 1 | Ustekinumab |
| Mochida Pharmaceutical Sales 持田製薬販売 | marketing (NHI list) | 1 | Pegfilgrastim |
| Mylan EPD | applicant (PMDA) | 1 | Darbepoetin alfa |
| Nipro ニプロ | marketing (NHI list) | 1 | Ustekinumab |
| SamChunDang Pharm. | applicant (PMDA), developer (KR) | 1 | Aflibercept |
| Samsung Bioepis | developer (KR) | 1 | Ustekinumab |
| Sanwa Kagaku Kenkyusho 三和化学研究所 | marketing (NHI list) | 1 | Darbepoetin alfa |
| Senju Pharmaceutical 千寿製薬 | marketing (NHI list) | 1 | Ranibizumab |
107 originator biologics on the NHI list have no Japanese biosimilar approval and a first re-examination period that has ended or ends within 3 years. The first 30, ranked by how many biosimilars the EU has already approved:
A re-exam period that has ended does not mean a biosimilar can launch: patents, later indications and development time still apply. Names only; we do not assess patents.
How Japan pays hospitals, pharmacies and doctors to switch (1 point = ¥10). Summary only; the MHLW documents prevail.
| Revision | What changed | Setting | Source |
|---|---|---|---|
| FY2020 | New biosimilar introduction add-on: 150 points a month for up to 3 months from the first prescription (1 point = ¥10) | Home self-injection | MHLW |
| FY2022 | Same add-on extended to outpatient chemotherapy | Outpatient cancer injections | MHLW |
| FY2024 | Add-on extended to all outpatient injections; new inpatient biosimilar use-system add-on (100 points per admission; hospital must reach 80% or 50% biosimilar share per molecule) | Outpatient + inpatient | MHLW |
| FY2026 (from 1 Jun 2026) | Inpatient add-on molecule list widened to 20 and claimed on the discharge day; new pharmacy biosimilar dispensing add-on (50 points, insulins excluded); generic-name prescribing bonus opened to biologics with a biosimilar (pharmacy overview) | Inpatient, pharmacy, prescriptions | MHLW |
| FY2026 pricing (Apr 2026) | Originator biologics with a biosimilar now get the G1 step-down; bio-AGs listed from October 2026 are priced at the originator's price. Biosimilars priced at or above the originator lose add-on eligibility (eligibility notice) | NHI pricing | MHLW |
| Practice rules (1 Jun 2026) | Doctors must endeavour to consider biosimilars; pharmacies must endeavour to stock them and dispense them on generic-name prescriptions. A brand-name originator prescription still cannot be switched. | All | MHLW |
| Co-pay | The long-listed-product surcharge (選定療養) excludes biologics, including after its June 2026 increase. | Patients | MHLW |
New biosimilars are listed at 0.7× the originator's NHI price, plus up to 10% depending on the clinical trial package. More than 70% of biosimilar marketers make the drug substance abroad, and marketers must supply for at least 5 years after listing (MHLW policy, 2024).
49 biosimilar designations for 23 reference biologics (PMDA list as of 2026-09); 112 biosimilar products are on the NHI price list.
Only for Ranmark 120 mg (Fuji Pharma, developed by Alvotech; approved 19 Sep 2025, NHI-listed 20 May 2026). No biosimilar of Pralia (Prolia) 60 mg for osteoporosis is approved in Japan.
Yes, four Eylea 2 mg biosimilar designations are approved. Fuji Pharma (developer Alvotech) launched on 7 Jan 2026, excluding diabetic macular edema, and may sell for all approved indications from 1 Nov 2026. Eylea 8 mg has no biosimilar.
Celltrion Healthcare Japan, Fuji Pharma, Mochida, Pfizer Japan, Daiichi Sankyo, Nichi-Iko, Nippon Kayaku, JCR, Sandoz, Nipro and others. Many products are developed abroad (Celltrion, Alvotech, Samsung Bioepis, Gedeon Richter) and sold by a Japanese partner.
There is no separate biologics exclusivity. The re-examination period (usually 8 years, up to 10 for orphan drugs) blocks biosimilar filings; patents may be extended by up to 5 years, and patent linkage applies.
By the end of FY2029, biosimilars should hold at least 80% of volume in at least 60% of the molecules that have a biosimilar. In FY2024 the figure was 22.2% (4 of 18 molecules).
A new biosimilar is listed at 0.7 times the originator's NHI price, plus up to 10% depending on its clinical trial package. After later price revisions the current median is 62% of the originator at the same strength.
It is our own calculation from MHLW's NDB open data: biosimilar volume (converted to active ingredient) divided by biosimilar plus reference-product volume, all settings combined. It is not an official MHLW figure.
Sources: PMDA “List of approved biosimilars” (as of 2026-09) and MHLW NHI drug price list, used under the Public Data License 1.0 — processed and translated by Japan Pharma Regulatory Brief (unofficial). Uptake figures are our own calculation from MHLW NDB open data. Company facts from each company's official release (linked). See the MHLW terms of use and PMDA's site policy. This page is not made by, affiliated with or endorsed by PMDA or MHLW. The Japanese originals prevail. Information only; not legal, medical or investment advice.
出典：独立行政法人医薬品医療機器総合機構（PMDA）『承認品目一覧（バイオ後続品）』、厚生労働省『薬価基準収載品目リスト』、『後発医薬品の有無に関する情報』、『NDBオープンデータ』、社会保障審議会医療保険部会・中央社会保険医療協議会の資料を加工して Japan Pharma Regulatory Brief が作成
Last built: · data as of 2026-09-28.