Live FDA Pipeline Intelligence · Updated 02/25/2026

The formulary decisions your competitors
make next quarter —visible now.

Formulary parses FDA filings, patent cliffs, and pipeline catalogs into actionable drug-launch timelines — before the street prices them in.

PDUFA Date: 01/2026

Tabelecleucel · BLA Priority

Patent Cliff: Adalimumab

Biosimilar Switch Window Open

Phase III Readout: Q2 2026

ENHERTU + Pertuzumab · HER2+

BLA Accepted: Orca-T

PDUFA: 04/06/2026 · AML/ALL/MDS

50 New Approvals · FY2024

48% First-in-Class · 52% Rare Disease

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// THE PROBLEM

The FDA never stops filing.
Neither does the noise.

3,494 goal-closing actions in FY2023. 1,690 submissions under active review right now. Every NDA, BLA, and ANDA matters — but not equally, and not right now.

fda_submissions_live.log
001NDA 217664 — Leqembi (lecanemab) · Biogen · Alzheimer's · APPROVED
002BLA 761244 — Orca-T · Orca Bio · AML/ALL/MDS · PDUFA 04/06/2026
003ANDA 215891 — Adalimumab-adaz · Sandoz · Biosimilar · LAUNCHED
004NDA 218101 — Suzetrigine · Vertex · Acute Pain · APPROVED
005BLA 761312 — Tabelecleucel · Atara · EBV+ PTLD · PDUFA 01/10/2026
006ANDA 216003 — Ustekinumab-stba · Samsung Bioepis · Biosimilar · REVIEW
007NDA 215659 — Dordaviprone · Day One · DIPG · APPROVED
008BLA 761290 — Zenocutuzumab · Merus · NRG1+ Cancer · APPROVED
009NDA 218102 — Amlitelimab · Sanofi · Atopic Dermatitis · PDUFA Q3 2026
010ANDA 217003 — Bevacizumab-maly · Amneal · Biosimilar · LAUNCHED
011NDA 218509 — Linvoseltamab · Regeneron · Multiple Myeloma · REVIEW
012BLA 761298 — Dato-DXd · Daiichi Sankyo · NSCLC · PDUFA Q2 2026
013NDA 217811 — Imetelstat · Geron · MDS · APPROVED
014ANDA 216778 — Infliximab-dyyb · Celltrion · Biosimilar · LAUNCHED
015NDA 218003 — Zipalertinib · Blueprint · NSCLC EGFR Exon 20 · REVIEW
016BLA 761301 — Afami-cel · Adaptimmune · Synovial Sarcoma · APPROVED
017NDA 218210 — Tovorafenib · Day One · Pediatric glioma · APPROVED
018ANDA 217556 — Denosumab-bnht · Amgen · Biosimilar · LAUNCHED
019NDA 218405 — Inavolisib · Genentech · PIK3CA+ Breast · APPROVED
020BLA 761315 — Obecabtagene · Autolus · ALL · APPROVED
001NDA 217664 — Leqembi (lecanemab) · Biogen · Alzheimer's · APPROVED
002BLA 761244 — Orca-T · Orca Bio · AML/ALL/MDS · PDUFA 04/06/2026
003ANDA 215891 — Adalimumab-adaz · Sandoz · Biosimilar · LAUNCHED
004NDA 218101 — Suzetrigine · Vertex · Acute Pain · APPROVED
005BLA 761312 — Tabelecleucel · Atara · EBV+ PTLD · PDUFA 01/10/2026
006ANDA 216003 — Ustekinumab-stba · Samsung Bioepis · Biosimilar · REVIEW
007NDA 215659 — Dordaviprone · Day One · DIPG · APPROVED
008BLA 761290 — Zenocutuzumab · Merus · NRG1+ Cancer · APPROVED
009NDA 218102 — Amlitelimab · Sanofi · Atopic Dermatitis · PDUFA Q3 2026
010ANDA 217003 — Bevacizumab-maly · Amneal · Biosimilar · LAUNCHED
011NDA 218509 — Linvoseltamab · Regeneron · Multiple Myeloma · REVIEW
012BLA 761298 — Dato-DXd · Daiichi Sankyo · NSCLC · PDUFA Q2 2026
013NDA 217811 — Imetelstat · Geron · MDS · APPROVED
014ANDA 216778 — Infliximab-dyyb · Celltrion · Biosimilar · LAUNCHED
015NDA 218003 — Zipalertinib · Blueprint · NSCLC EGFR Exon 20 · REVIEW
016BLA 761301 — Afami-cel · Adaptimmune · Synovial Sarcoma · APPROVED
017NDA 218210 — Tovorafenib · Day One · Pediatric glioma · APPROVED
018ANDA 217556 — Denosumab-bnht · Amgen · Biosimilar · LAUNCHED
019NDA 218405 — Inavolisib · Genentech · PIK3CA+ Breast · APPROVED
020BLA 761315 — Obecabtagene · Autolus · ALL · APPROVED
1,690 UNDER REVIEW

↑ UNFILTERED FDA SUBMISSION STREAM

FORMULARY ALERT · IMMUNOLOGY
COMMAND ACCESS

Adalimumab Biosimilar Switch

Patent Cliff: Open Since 01/2023

CVS converted 97% of Humira use to biosimilars by Aug 2024. OptumRx and Express Scripts following with private-label products. Current market split: 62% AbbVie / 38% biosimilar. Projected 50/50 within 6 months.

Switch window is now. 73 FDA-approved biosimilars. Formulary dossier template ready.

73
FDA-Approved Biosimilars
38%
Current Market Share
6mo
To 50/50 Split

↑ ONE FORMULARY-READY INSIGHT

// INTELLIGENCE TIERS

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IMMUNOLOGY · BIOSIMILAR SWITCHUpdated 02/25/2026

Adalimumab Biosimilar Formulary Dossier

34 pagesBRIEF #001
CVS Health private-label conversion achieved 97% penetration among commercial enrollees by August 2024. OptumRx and Express Scripts are expected to complete similar transitions by Q2 2026, with an estimated net formulary savings of across the three major PBMs. The recommended switch protocol for hospital formularies involves$847M–$1.2B annually across the three major PBMs. The recommended switch protocol for hospital formularies involves a 90-day transition window with concurrent patient notification and prior authorization pathway modification.
AdalimumabBiosimilarPBM StrategyFormulary Switch
COMMAND ACCESS REQUIRED🔒
ONCOLOGY · CELL THERAPY · BLAUpdated 02/24/2026

Orca-T Pipeline Intelligence Brief

28 pagesBRIEF #002
Orca-T BLA accepted with Priority Review. PDUFA target: April 6, 2026. Indication: AML, ALL, MDS — allogeneic cell therapy. Key differentiator vs. CAR-T: donor-specific T-regulatory cell enrichment reducing GvHD incidence to allogeneic SCT. Formulary placement decision window opens12% vs. 38% standard allogeneic SCT. Formulary placement decision window opens December 2025 for institutions with active hematology formulary review cycles.
Cell TherapyAMLBLA PriorityPDUFA 04/2026
COMMAND ACCESS REQUIRED🔒
ONCOLOGY · PIPELINE · MULTI-ASSETUpdated 02/23/2026

Phase III Oncology Pipeline — Q2 2026 Readout Calendar

51 pagesBRIEF #003
14 Phase III readouts anticipated Q2 2026 across oncology. High-conviction signals identified in HER2-low breast cancer (dato-DXd), KRAS G12C NSCLC (second-line), and NRG1 fusion-positive cancers. Budget impact models for each asset are included, anging from $18,000–$42,000/month. Managed care contractingwith WAC estimates ranging from $18,000–$42,000/month. Managed care contracting strategy recommendations for each therapeutic class are detailed in Section 4.
Phase IIIHER2-lowKRAS G12CQ2 Readouts
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