Database scope
466
Total rows (presentation × source)
126
Unique INNs (normalized)
376
Unique products (brand)
By regulatory source — row count
205
FDA Label rows
112 unique INNs · 180 unique products
261
EMA SmPC rows
108 unique INNs · 227 unique products
94
INN overlap (FDA ∩ EMA)
substance level
By regulatory source — unique products (brand)
180
FDA unique products
brand_name 단위
227
EMA unique products
EMA는 농도/제형이 product_name에 포함
31
동일 product_name (FDA ∩ EMA)
180 + 227 − 31 = 376 total
Originator vs biosimilar
289
Originator rows
232 brands
177
Biosimilar rows
144 brands
26
IV/SC dual mAbs
SC transition
Whole mAb 정책 적용: Bispecific(15), ADC(2), Fab fragment(1), 진단용(2) 항체는 제외.
Hyaluronidase 조합제와 INMAZEB/OPDUALAG/Phesgo/Ronapreve/Evusheld 같은 다중 mAb 조합은 유지.
Substance distribution
18
FDA only
94
Both
14
EMA only
126
Total unique
농도 분포는 250 mg/mL에서 클립됨. SC: 100-200 mg/mL 고농도 / IV concentrate: 5-30 mg/mL 일반적.
Extraction completeness
369
F% extracted
79.2%
362
CL extracted
77.7%
391
Vd extracted
83.9%
466
API conc
100.0%
IV → SC transition pairs
26
Dual-route INNs
26
With concentration data
5.5×
Mean SC/IV fold-increase
Coverage vs Prof. Park PhaseW
112/115
FDA INN
97.4%
108/107
EMA INN
100.9%
96.0%
Combined FDA∪EMA
119/124
커버리지 추적: v1 92.7% → v2 94.4% → v3 95.2% → v3.1 96.0%
남은 누락 5개는 모두 정책적 제외:
남은 누락 5개는 모두 정책적 제외:
- ADC 2개: datopotamab (Datroway), tisotumab (Tivdak)
- INMAZEB 분리 카운팅: maftivimab, odesivimab
- 임상 중단: dalotuzumab
전체 DB 행 검색 / 필터 / 다운로드
사용법: 상단 검색창에 키워드 입력 (예: "humira", "FDA", "SC"), 컬럼별 정렬, CSV/Excel 다운로드, 인쇄 가능. 필터 패널로 세분화 검색 가능.
| id | Source | Product | Substance | INN | Manufacturer | Route | Form | Conc (mg/mL) | Strength label | F (%) | CL (L/day) | Vd (L) | TMDD | Biosim |
|---|
Substance-level 요약 (INN별 그룹)
| INN (normalized) | Approval | Routes | # Rows | # Brands | Has biosim | F (mean %) | CL (mean L/day) | Vd (mean L) |
|---|