Japan Biosimilar Tracker · インフリキシマブ(遺伝子組換え)
Every Infliximab biosimilar approved in Japan against Remicade: 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: Remicade (レミケード; 田辺ファーマ). ← All biosimilars in Japan
| Approved | Designation | Applicant | Developer (verified) | Product (PMDA English list) |
|---|---|---|---|---|
| 2014-07-04 | infliximab biosimilar 1 インフリキシマブ後続1 | Celltrion | Celltrion [basis] | (1) Infliximab BS for I.V. Infusion 100 mg “NK” (Nippon Kayaku Co., Ltd.) (2) Infliximab BS for I.V. Infusion 100 mg “CTH” |
| 2017-09-27 | infliximab biosimilar 2 インフリキシマブ後続2 | Yakuhan Pharmaceutical | – | Infliximab BS for I.V. Infusion 100 mg “Nichiiko” (Nichi-Iko Pharmaceutical Co., Ltd.) Infliximab BS for I.V. Infusion 100 mg “AYUMI” |
| 2018-07-02 | infliximab biosimilar 3 インフリキシマブ後続3 | Pfizer Japan | – | Infliximab BS for I.V. Infusion 100 mg [Pfizer] |
One row per product and strength. Price ratio = biosimilar NHI price ÷ Remicade NHI price at the identical NHI strength (“–” when no originator has the same strength).
| Product | Strength | Company | Approved | NHI listed | Launch | Price ratio | Status |
|---|---|---|---|---|---|---|---|
| インフリキシマブBS点滴静注用100mg「NK」 | 100mg1瓶 | Celltrion Healthcare Japan developer: Celltrion | 2014-07-04 | – | – | 40% | listed |
| インフリキシマブBS点滴静注用100mg「あゆみ」 | 100mg1瓶 | Ayumi Pharmaceutical | 2017-09-27 | 2017-11-29 ≈ first seen on the list; between 2017-11-22 and 2017-11-29 | – | 47% | listed (transitional) until R9.3.31まで |
| インフリキシマブBS点滴静注用100mg「日医工」 | 100mg1瓶 | Nichi-Iko Pharmaceutical | 2017-09-27 | 2017-11-29 ≈ first seen on the list; between 2017-11-22 and 2017-11-29 | – | 35% | listed (transitional) until R9.3.31まで |
| インフリキシマブBS点滴静注用100mg「ファイザー」 | 100mg1瓶 | Pfizer Japan | 2018-07-02 | 2018-11-28 ≈ first seen on the list; between 2018-11-20 and 2018-11-28 | – | 38% | 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 | 29.1% | NDB open data (FY2022) |
| FY2023 | 34.5% | NDB open data (FY2023) |
| FY2024 | 41.3% | 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 |
|---|---|---|---|---|---|
| 2018-11-28 | NHI listing | Infliximab | Pfizer Japan | [infliximab biosimilar 3] インフリキシマブBS点滴静注用100mg「ファイザー」 38% of originator | [source] |
| 2018-07-02 | Approval | Infliximab | Pfizer Japan | [infliximab biosimilar 3] | [source] |
| 2017-11-29 | NHI listing | Infliximab | Ayumi Pharmaceutical | [infliximab biosimilar 2] インフリキシマブBS点滴静注用100mg「あゆみ」, インフリキシマブBS点滴静注用100mg「日医工」 35%–47% of originator | [source] |
| 2017-09-27 | Approval | Infliximab | Yakuhan Pharmaceutical | [infliximab biosimilar 2] | [source] |
| 2014-07-04 | Approval | Infliximab | Celltrion | [infliximab 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.