Japan Biosimilar Tracker · アフリベルセプト(遺伝子組換え)
Every Aflibercept biosimilar approved in Japan against Eylea: 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: Eylea (アイリーア, アイリーア8mg; バイエル薬品). ← All biosimilars in Japan
| Approved | Designation | Applicant | Developer (verified) | Product (PMDA English list) |
|---|---|---|---|---|
| 2024-06-24 | aflibercept biosimilar 1 アフリベルセプト後続1 | Global Regulatory Partners | – | Aflibercept BS Solution for Intravitreal Injection 40 mg/mL "GRP" |
| 2025-09-19 | aflibercept biosimilar 3 アフリベルセプト後続3 | SamChunDang Pharm. | SamChunDang Pharm. [basis] | Aflibercept BS Solution for Intravitreal Injection 40 mg/mL "SCD" Aflibercept BS Kit for Intravitreal Injection 40 mg/mL "SCD" |
| 2025-09-19 | aflibercept biosimilar 2 アフリベルセプト後続2 | Fuji Pharma | Alvotech [basis] | Aflibercept BS Solution 40 mg/mL for IVT Injection "NIT" Aflibercept BS Kit 40 mg/mL for IVT Injection "NIT" |
| 2026-03-23 | aflibercept biosimilar 4 アフリベルセプト後続4 | Celltrion Healthcare Japan | Celltrion [basis] |
One row per product and strength. Price ratio = biosimilar NHI price ÷ Eylea NHI price at the identical NHI strength (“–” when no originator has the same strength).
| Product | Strength | Company | Approved | NHI listed | Launch | Price ratio | Status |
|---|---|---|---|---|---|---|---|
| アフリベルセプトBS硝子体内注射液 40 mg/mL「GRP」 | – | Global Regulatory Partners | 2024-06-24 | – | – | – | approved, not NHI-listed |
| アフリベルセプトBS硝子体内注射液40 mg/mL「SCD」 | – | SamChunDang Pharm. developer: SamChunDang Pharm. | 2025-09-19 | – | – | – | approved, not NHI-listed |
| アフリベルセプトBS硝子体内注射液40mg/mL「NIT」 | 2mg0.05mL1瓶 | Fuji Pharma developer: Alvotech | 2025-09-19 | 2025-11-12 ≈ first seen on the list; between 2025-10-22 and 2025-11-12 | 2026-01-07 | 68% | listed |
| アフリベルセプトBS硝子体内注射用キット40mg/mL「NIT」 | 2mg0.05mL1筒 | Fuji Pharma developer: Alvotech | 2025-09-19 | 2025-11-12 ≈ first seen on the list; between 2025-10-22 and 2025-11-12 | 2026-01-07 | 68% | listed |
| アフリベルセプトBS硝子体内注射液40 mg/mL「CT」 | – | Celltrion Healthcare Japan developer: Celltrion | 2026-03-23 | – | – | – | approved, not NHI-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).
| Date | Event | Ingredient | Company | Details | Source |
|---|---|---|---|---|---|
| 2026-03-23 | Approval | Aflibercept | Celltrion Healthcare Japan | [aflibercept biosimilar 4] | [source] |
| 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] |
| 2025-11-12 | 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] |
| 2025-09-19 | Approval | Aflibercept | Fuji Pharma (developer: Alvotech) | [aflibercept biosimilar 2] | [source] |
| 2025-09-19 | Approval | Aflibercept | SamChunDang Pharm. | [aflibercept biosimilar 3] | [source] |
| 2024-06-24 | Approval | Aflibercept | Global Regulatory Partners | [aflibercept 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.