The reference layer for biologics and cell/gene therapy.
Search any biologic. Verify any sponsor. Surface the regulatory pathway, designation history, and competitive context that single-source databases don't carry — built for biotech BD, regulatory affairs, and competitive intelligence teams who need answers, not headlines.
Live data fetched from biologics_api.brief()
Built on the largest unified biologics data layer.
Every BLA, every ATMP designation, every confirmatory trial — reconciled across FDA CBER, EMA CAT, PMDA, MHRA, Health Canada BGTD, NMPA, and CDSCO. The numbers update at every build. No stale screenshots.
Linked into the global regulatory graph.
BiologicsIQ products carry external identifiers that connect them across regulators and the global nomenclature graph. Linkage rates below — current build.
Beyond the regulator's database.
The four categories of biologics intelligence that single-source databases don't carry. Cross-cutting, structured, queryable.
Cross-regulator product profiles
One profile per biologic, reconciled across FDA, EMA, PMDA, MHRA, Health Canada, NMPA, and CDSCO. Designation history, classification, regulatory pathway, exclusivity expiry — joined at the product level, not chased across portals.
Confirmatory-trial lifecycle (FDORA)
FDA accelerated approvals tracked from grant through confirmatory-trial readout. Per-product status: planned · enrolling · underway · readout pending · converted to full · failed to confirm · withdrawn by sponsor · withdrawn by FDA.
ATMP + cell/gene depth
EMA CAT classification (GTMP / sCTMP / TEP / combined ATMP), 2025 comparability-guideline era flag, vector serotype, cell source, ex-vivo vs in-vivo, transgene — modality-specific fields competitors collapse into 'gene therapy'.
Source-level provenance
Every gold row walks back through silver lineage, the bronze raw payload, and the adapter run that fetched it. Cite source PDFs in regulatory submissions and BD memos with confidence — no claim is unsourced.
See the data your BD decision deserves.
Each BiologicsIQ product page bundles regulatory status, designation history, indication-level approvals, confirmatory-trial lifecycle, manufacturing sites, adverse-event signals, and HTA decisions. One page, one source of truth.
- Regulatory status across FDA, EMA, PMDA, MHRA, HC, NMPA, CDSCO
- Designation history (Orphan · Breakthrough · RMAT · PRIME · Sakigake · ILAP)
- Indication-level approvals with conversion-to-full dates
- Confirmatory-trial lifecycle for accelerated approvals (FDORA)
- Linked manufacturing sites with FDA inspection status
- Adverse-event signals with disproportionality scoring
- HTA outcomes from NICE / ICER / G-BA / HAS / CADTH / PBAC
- Source attribution for every claim — full provenance walk-back
biologicsiq.ai/product/vyvgart-efgartigimod-alfa/Three pieces. One coherent product.
Ingest authoritative sources
FDA Drugs@FDA + Purple Book, EMA EPAR + CHMP opinions + CAT register, PMDA approvals + JADER, MHRA + Yellow Card, Health Canada DPD + Vigilance, NMPA CDE, CDSCO Biologics, ClinicalTrials.gov + EU CTR + CTIS, WHO INN + PQ, FAERS + EudraVigilance. Continuous refresh on a 24-hour to 7-day cadence depending on source class.
Canonicalise at the drug-substance level
INN-anchored canonical drug substances. Sponsor identity reconciled across DUNS / LEI / FEI / EMA org ID / PMDA MAH ID. Manufacturing sites linked at FDA establishment-ID granularity. Crosswalks at the molecule + sponsor level, never at the brand-name level.
Surface the intelligence layer
Regulatory status, designation history, confirmatory-trial lifecycle, ATMP classification, adverse-event signals, HTA outcomes — exposed via REST API and a queryable data product. Not buried in PDFs.
People who need answers, not headlines.
Biotech BD / licensing
Sponsor pipeline depth, exclusivity-cliff watch, target competitive landscapes, licensing comp search. When a $500M deal hangs on a regulatory timeline, you get an authoritative answer in under a second.
Regulatory affairs
Confirmatory-trial lifecycle tracking. FDA CBER OTP super-office filings. EMA CAT classification under 2025 comparability guidance. Cite source PDFs in submissions without hunting for them.
Competitive intelligence
Designation grants the same week they happen. Label-change feed. Pharmacovigilance signals from FAERS / EudraVigilance / JADER summarised at the product level. Weekly automated brief.
Market access / HEOR
HTA outcomes from NICE / ICER / G-BA / HAS / CADTH / PBAC linked to products. Pricing observations across regions. Biosimilar competition graph for cliff modelling.
Every claim has a source. Every product has a regulatory anchor.
Tier-A profiles follow a 22-section playbook with explicit regulatory anchoring and source attribution. Safety-critical fields refresh every 60 days. The full operating contract is public.
Tier-A biologic profiles
Class III biologics + ATMPs get a 22-section profile with regulatory anchor, designation lineage, confirmatory-trial chain, and post-market signal.
Source attribution per field
Each fact carries an attribution row — source, retrieval date, reviewer, decay clock. No claim is unsourced.
Trust tiers
Three explicit tiers: unverified (registry-only), AI-reviewed (cross-checked), expert-reviewed (signed off by regulatory affairs).
Refresh cadence
Safety-critical fields: 60 days. Regulatory + designation: weekly. FAERS / vigilance: quarterly. Last refresh shown on every page.
BiologicsIQ is in private preview.
We're onboarding biotech BD, regulatory affairs, market access, and competitive intelligence teams in waves. Tell us how you'd use BiologicsIQ and we'll get back within 2 business days.
- ✓ Verified researchers receive free access
- ✓ Biotech and pharma reviewed individually
- ✓ Approval typically within 2 business days
- ✓ No spam, ever