Japan Biosimilar Tracker · アダリムマブ(遺伝子組換え)
Every Adalimumab biosimilar approved in Japan against Humira: who sells it, when it was approved, listed and launched, its price versus the originator, and uptake.
Last updated: 2026-09-28 · PMDA biosimilar list as of 2026-09
Originator: Humira (ヒュミラ; アッヴィ). ← All biosimilars in Japan
| Approved | Designation | Applicant | Developer (verified) | Product (PMDA English list) |
|---|---|---|---|---|
| 2020-06-29 | adalimumab biosimilar 1 アダリムマブ後続1 | Fujifilm Kyowa Kirin Biologics | – | Adalimumab BS Subcutaneous Injection 40 mg Syringe 0.8 mL “FKB” Adalimumab BS Subcutaneous Injection 40 mg Pen 0.8 mL “FKB” Adalimumab BS Subcutaneous Injection 20 mg Syringe 0.4 mL “FKB” |
| 2021-01-22 | adalimumab biosimilar 2 アダリムマブ後続2 | Daiichi Sankyo | – | Adalimumab BS Subcutaneous Injection 20 mg Syringe 0.4 mL ”Daiichi Sankyo” Adalimumab BS Subcutaneous Injection 40 mg Syringe 0.8 mL ”Daiichi Sankyo” Adalimumab BS Subcutaneous Injection 40 mg Pen 0.8 mL ”Daiichi Sankyo” |
| 2021-03-23 | adalimumab biosimilar 3 アダリムマブ後続3 | Mochida Pharmaceutical | – | Adalimumab BS Subcutaneous Injection 20 mg Syringe 0.2 mL "MA" Adalimumab BS Subcutaneous Injection 40 mg Syringe 0.4 mL "MA" Adalimumab BS Subcutaneous Injection 80 mg Syringe 0.8 mL "MA" Adalimumab BS Subcutaneous Injection 40 mg Pen 0.4 mL "MA" |
| 2023-09-25 | adalimumab biosimilar 4 アダリムマブ後続4 | Nippon Kayaku | Celltrion [basis] | Adalimumab BS Subcutaneous Injection 20 mg Syringe 0.2 mL "CTNK" Adalimumab BS Subcutaneous Injection 40 mg Syringe 0.4 mL "CTNK" Adalimumab BS Subcutaneous Injection 80 mg Syringe 0.8 mL "CTNK" Adalimumab BS Subcutaneous Injection 40 mg Pen 0.4 mL "CTNK" Adalimumab BS Subcutaneous Injection 80 mg Pen 0.8 mL "CTNK" |
One row per product and strength. Price ratio = biosimilar NHI price ÷ Humira NHI price at the identical NHI strength (“–” when no originator has the same strength).
| Product | Strength | Company | Approved | NHI listed | Launch | Price ratio | Status |
|---|---|---|---|---|---|---|---|
| アダリムマブBS皮下注20mgシリンジ0.4mL「FKB」 | 20mg0.4mL1筒 | Fujifilm Kyowa Kirin Biologics | 2020-06-29 | 2020-11-25 ≈ first seen on the list; between 2020-11-18 and 2020-11-25 | – | – | listed |
| アダリムマブBS皮下注40mgシリンジ0.8mL「FKB」 | 40mg0.8mL1筒 | Fujifilm Kyowa Kirin Biologics | 2020-06-29 | 2020-11-25 ≈ first seen on the list; between 2020-11-18 and 2020-11-25 | – | – | listed |
| アダリムマブBS皮下注40mgペン0.8mL「FKB」 | 40mg0.8mL1キット | Fujifilm Kyowa Kirin Biologics | 2020-06-29 | 2020-11-25 ≈ first seen on the list; between 2020-11-18 and 2020-11-25 | – | – | listed |
| アダリムマブBS皮下注20mgシリンジ0.4mL「第一三共」 | 20mg0.4mL1筒 | Daiichi Sankyo | 2021-01-22 | 2021-05-26 ≈ first seen on the list; between 2021-05-19 and 2021-05-26 | – | – | listed |
| アダリムマブBS皮下注40mgシリンジ0.8mL「第一三共」 | 40mg0.8mL1筒 | Daiichi Sankyo | 2021-01-22 | 2021-05-26 ≈ first seen on the list; between 2021-05-19 and 2021-05-26 | – | – | listed |
| アダリムマブBS皮下注40mgペン0.8mL「第一三共」 | 40mg0.8mL1キット | Daiichi Sankyo | 2021-01-22 | 2021-05-26 ≈ first seen on the list; between 2021-05-19 and 2021-05-26 | – | – | listed |
| アダリムマブBS皮下注20mgシリンジ0.2mL「MA」 | 20mg0.2mL1筒 | Mochida Pharmaceutical | 2021-03-23 | 2021-11-25 ≈ first seen on the list; between 2021-11-01 and 2021-11-25 | – | 45% | listed |
| アダリムマブBS皮下注40mgシリンジ0.4mL「MA」 | 40mg0.4mL1筒 | Mochida Pharmaceutical | 2021-03-23 | 2021-11-25 ≈ first seen on the list; between 2021-11-01 and 2021-11-25 | – | 42% | listed |
| アダリムマブBS皮下注40mgペン0.4mL「MA」 | 40mg0.4mL1キット | Mochida Pharmaceutical | 2021-03-23 | 2021-11-25 ≈ first seen on the list; between 2021-11-01 and 2021-11-25 | – | 44% | listed |
| アダリムマブBS皮下注80mgシリンジ0.8mL「MA」 | 80mg0.8mL1筒 | Mochida Pharmaceutical | 2021-03-23 | 2021-11-25 ≈ first seen on the list; between 2021-11-01 and 2021-11-25 | – | 42% | listed |
| アダリムマブBS皮下注20mgシリンジ0.2mL「CTNK」 | 20mg0.2mL1筒 | Nippon Kayaku developer: Celltrion | 2023-09-25 | 2023-11-22 ≈ first seen on the list; between 2023-11-01 and 2023-11-22 | – | 44% | listed |
| アダリムマブBS皮下注40mgシリンジ0.4mL「CTNK」 | 40mg0.4mL1筒 | Nippon Kayaku developer: Celltrion | 2023-09-25 | 2023-11-22 ≈ first seen on the list; between 2023-11-01 and 2023-11-22 | – | 39% | listed |
| アダリムマブBS皮下注40mgペン0.4mL「CTNK」 | 40mg0.4mL1キット | Nippon Kayaku developer: Celltrion | 2023-09-25 | 2023-11-22 ≈ first seen on the list; between 2023-11-01 and 2023-11-22 | – | 40% | listed |
| アダリムマブBS皮下注80mgシリンジ0.8mL「CTNK」 | 80mg0.8mL1筒 | Nippon Kayaku developer: Celltrion | 2023-09-25 | 2023-11-22 ≈ first seen on the list; between 2023-11-01 and 2023-11-22 | – | 35% | listed |
| アダリムマブBS皮下注80mgペン0.8mL「CTNK」 | 80mg0.8mL1キット | Nippon Kayaku developer: Celltrion | 2023-09-25 | 2023-11-22 ≈ first seen on the list; between 2023-11-01 and 2023-11-22 | – | 40% | listed |
Product names are as on the MHLW NHI list (Japanese). Launch dates only where the company published one. Yen prices for every strength and their history: subscribers only
| Fiscal year | Biosimilar volume share | Data |
|---|---|---|
| FY2022 | 11.1% | NDB open data (FY2022) |
| FY2023 | 16.9% | NDB open data (FY2023) |
| FY2024 | 26.6% | NDB open data (FY2024) |
own calculation from MHLW NDB open data: biosimilar volume ÷ (biosimilar + reference product), converted to active ingredient, all settings combined. Not an official MHLW figure. DPC-bundled inpatient use is missing and cells under 400 are hidden (counted as 0), so small products are underestimated. Inpatient / outpatient split and value share: subscribers.
| Date | Event | Ingredient | Company | Details | Source |
|---|---|---|---|---|---|
| 2023-11-22 | NHI listing | Adalimumab | Nippon Kayaku (developer: Celltrion) | [adalimumab biosimilar 4] アダリムマブBS皮下注20mgシリンジ0.2mL「CTNK」, アダリムマブBS皮下注40mgシリンジ0.4mL「CTNK」, アダリムマブBS皮下注80mgシリンジ0.8mL「CTNK」… 35%–44% of originator | [source] |
| 2023-09-25 | Approval | Adalimumab | Nippon Kayaku (developer: Celltrion) | [adalimumab biosimilar 4] | [source] |
| 2021-11-25 | NHI listing | Adalimumab | Mochida Pharmaceutical | [adalimumab biosimilar 3] アダリムマブBS皮下注20mgシリンジ0.2mL「MA」, アダリムマブBS皮下注40mgシリンジ0.4mL「MA」, アダリムマブBS皮下注80mgシリンジ0.8mL「MA」… 42%–45% of originator | [source] |
| 2021-05-26 | NHI listing | Adalimumab | Daiichi Sankyo | [adalimumab biosimilar 2] アダリムマブBS皮下注20mgシリンジ0.4mL「第一三共」, アダリムマブBS皮下注40mgシリンジ0.8mL「第一三共」, アダリムマブBS皮下注40mgペン0.8mL「第一三共」 | [source] |
| 2021-03-23 | Approval | Adalimumab | Mochida Pharmaceutical | [adalimumab biosimilar 3] | [source] |
| 2021-01-22 | Approval | Adalimumab | Daiichi Sankyo | [adalimumab biosimilar 2] | [source] |
| 2020-11-25 | NHI listing | Adalimumab | Fujifilm Kyowa Kirin Biologics | [adalimumab biosimilar 1] アダリムマブBS皮下注20mgシリンジ0.4mL「FKB」, アダリムマブBS皮下注40mgシリンジ0.8mL「FKB」, アダリムマブBS皮下注40mgペン0.8mL「FKB」 | [source] |
| 2020-06-29 | Approval | Adalimumab | Fujifilm Kyowa Kirin Biologics | [adalimumab biosimilar 1] | [source] |
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.