Japan Biosimilar Tracker · トラスツズマブ(遺伝子組換え)
Every Trastuzumab biosimilar approved in Japan against Herceptin: 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: Herceptin (ハーセプチン; 中外製薬). ← All biosimilars in Japan
| Approved | Designation | Applicant | Developer (verified) | Product (PMDA English list) |
|---|---|---|---|---|
| 2018-03-23 | trastuzumab biosimilar 1 トラスツズマブ後続1 | Celltrion | Celltrion [basis] | Trastuzumab BS for I.V. Infusion 60 mg "NK" Trastuzumab BS for I.V. Infusion 150 mg "NK" (Nippon Kayaku Co., Ltd.) Trastuzumab BS for I.V. Infusion 60 mg "CTH" Trastuzumab BS for I.V. Infusion 150 mg "CTH" |
| 2018-09-21 | trastuzumab biosimilar 3 トラスツズマブ後続3 | Pfizer Japan | – | Trastuzumab BS for Intravenous Infusion 60 mg [Pfizer] Trastuzumab BS for Intravenous Infusion 150 mg [Pfizer] |
| 2018-09-21 | trastuzumab biosimilar 2 トラスツズマブ後続2 | Daiichi Sankyo | – | Trastuzumab BS for Intravenous Drip Infusions 60 mg "Daiichi Sankyo" Trastuzumab BS for Intravenous Drip Infusions 150 mg "Daiichi Sankyo" |
One row per product and strength. Price ratio = biosimilar NHI price ÷ Herceptin NHI price at the identical NHI strength (“–” when no originator has the same strength).
| Product | Strength | Company | Approved | NHI listed | Launch | Price ratio | Status |
|---|---|---|---|---|---|---|---|
| トラスツズマブBS点滴静注用150mg「NK」 | 150mg1瓶 | Celltrion Healthcare Japan developer: Celltrion | 2018-03-23 | 2018-05-30 ≈ first seen on the list; between 2018-05-22 and 2018-05-30 | – | 42% | listed |
| トラスツズマブBS点滴静注用60mg「NK」 | 60mg1瓶 | Celltrion Healthcare Japan developer: Celltrion | 2018-03-23 | 2018-05-30 ≈ first seen on the list; between 2018-05-22 and 2018-05-30 | – | 41% | listed |
| トラスツズマブBS点滴静注用150mg「ファイザー」 | 150mg1瓶 | Pfizer Japan | 2018-09-21 | 2019-05-29 ≈ first seen on the list; between 2019-05-22 and 2019-05-29 | – | 41% | listed |
| トラスツズマブBS点滴静注用60mg「ファイザー」 | 60mg1瓶 | Pfizer Japan | 2018-09-21 | 2019-05-29 ≈ first seen on the list; between 2019-05-22 and 2019-05-29 | – | 40% | listed |
| トラスツズマブBS点滴静注用60mg「第一三共」 | – | Daiichi Sankyo | 2018-09-21 | – | – | – | delisted or discontinued |
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 | 65.7% | NDB open data (FY2022) |
| FY2023 | 73.8% | NDB open data (FY2023) |
| FY2024 | 80.1% | 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 |
|---|---|---|---|---|---|
| 2019-05-29 | NHI listing | Trastuzumab | Pfizer Japan | [trastuzumab biosimilar 3] トラスツズマブBS点滴静注用60mg「ファイザー」, トラスツズマブBS点滴静注用150mg「ファイザー」 40%–41% of originator | [source] |
| 2018-09-21 | Approval | Trastuzumab | Daiichi Sankyo | [trastuzumab biosimilar 2] | [source] |
| 2018-09-21 | Approval | Trastuzumab | Pfizer Japan | [trastuzumab biosimilar 3] | [source] |
| 2018-05-30 | NHI listing | Trastuzumab | Celltrion Healthcare Japan | [trastuzumab biosimilar 1] トラスツズマブBS点滴静注用60mg「NK」, トラスツズマブBS点滴静注用150mg「NK」 41%–42% of originator | [source] |
| 2018-03-23 | Approval | Trastuzumab | Celltrion | [trastuzumab 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.