Japan Biosimilar Tracker · デノスマブ(遺伝子組換え)
Every Denosumab biosimilar approved in Japan against Ranmark: 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: Ranmark (プラリア, ランマーク; 第一三共). ← All biosimilars in Japan
| Approved | Designation | Applicant | Developer (verified) | Product (PMDA English list) |
|---|---|---|---|---|
| 2025-09-19 | denosumab biosimilar 1 デノスマブ後続1 | Fuji Pharma | Alvotech [basis] | Denosumab BS 120 mg RM for S.C. Injection "F" |
One row per product and strength. Price ratio = biosimilar NHI price ÷ Ranmark NHI price at the identical NHI strength (“–” when no originator has the same strength).
| Product | Strength | Company | Approved | NHI listed | Launch | Price ratio | Status |
|---|---|---|---|---|---|---|---|
| デノスマブBS皮下注120mgRM「F」 | 120mg1.7mL1瓶 | Fuji Pharma developer: Alvotech | 2025-09-19 | 2026-05-20 MHLW NHI list remark | – | 55% | 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
No NDB figure yet: the first biosimilar was listed after FY2024 (the latest NDB open data covers April 2024 to March 2025).
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.