Assyro AI

Purple Book product · Interchangeable

Poherdy

pertuzumab-dpzb

351(k) InterchangeableBLA 761450RxLicensed Shanghai Henlius Biotech, Inc.

At a glance

Nov 13, 2025

Approved

Interchangeable

License type

Rx

Marketing

No

Patents listed

Key dates

  1. Approval

    Approval date of this BLA submission.

    Nov 13, 2025

    7 mo ago

  2. Today

Pharmaceutical detail

Strength

420MG/14ML (30MG/ML)

Dosage form

Injection

Route

Intravenous

Presentation

Single-Dose Vial

Center

CDER

License number

2354

Product number

001

Submission type

Original

Supplement number

Not listed

Change type

Not listed

Reference product family

View full family

Biosimilar of pertuzumab (Perjeta)

Patent list (47)

Patents published in the FDA Purple Book Patent List for this product, with expiration date and source link.
PatentExpiresInSource
7,862,817Jun 01, 20251 yr agoFDA
9,017,671Oct 19, 20258 mo agoFDA
7,449,184Mar 12, 20263 mo agoFDA
11,034,754May 23, 202612 d agoFDA
9,631,007May 23, 202612 d agoFDA
8,404,234Jul 03, 2026in 29 dFDA
8,372,396Jul 19, 2026in 2 moFDA
11,261,238May 28, 2028in 2 yrFDA
10,808,037Jul 08, 2028in 2 yr 2 moFDA
11,078,294Jul 08, 2028in 2 yr 2 moFDA
11,976,127Jul 08, 2028in 2 yr 2 moFDA
11,987,637Jul 08, 2028in 2 yr 2 moFDA
11,987,638Jul 08, 2028in 2 yr 2 moFDA
11,999,791Jul 08, 2028in 2 yr 2 moFDA
12,098,211Jul 08, 2028in 2 yr 2 moFDA
12,145,997Jul 08, 2028in 2 yr 2 moFDA
12,173,080Jul 08, 2028in 2 yr 2 moFDA
8,574,869Jul 08, 2028in 2 yr 2 moFDA
11,597,776Jan 28, 2029in 2 yr 8 moFDA
12,110,341Jan 28, 2029in 2 yr 8 moFDA
10,689,457Jun 15, 2029in 3 yr 1 moFDA
11,655,305Jun 15, 2029in 3 yr 1 moFDA
9,493,548Jun 22, 2029in 3 yr 1 moFDA
9,181,346Jul 18, 2029in 3 yr 2 moFDA
11,639,395Jul 30, 2029in 3 yr 2 moFDA
10,982,003Aug 06, 2030in 4 yr 3 moFDA
11,225,513Aug 06, 2030in 4 yr 3 moFDA
12,103,975Aug 06, 2030in 4 yr 3 moFDA
9,714,293Aug 06, 2030in 4 yr 3 moFDA
11,414,498Dec 23, 2030in 4 yr 7 moFDA
8,512,983Jan 04, 2031in 4 yr 8 moFDA
10,662,237Aug 07, 2031in 5 yr 3 moFDA
8,652,474Sep 28, 2031in 5 yr 5 moFDA
10,087,237Jan 21, 2032in 5 yr 9 moFDA
10,184,106Mar 15, 2033in 6 yr 11 moFDA
9,493,744Feb 24, 2034in 7 yr 10 moFDA
10,017,732Mar 14, 2034in 7 yr 11 moFDA
10,131,873Mar 14, 2034in 7 yr 11 moFDA
10,676,710Mar 14, 2034in 7 yr 11 moFDA
10,829,732Mar 14, 2034in 7 yr 11 moFDA
9,815,904Apr 15, 2034in 8 yrFDA
9,969,811Apr 15, 2034in 8 yrFDA
12,145,998Sep 07, 2034in 8 yr 5 moFDA
11,638,756Feb 28, 2038in 11 yr 11 moFDA
12,128,103Feb 28, 2038in 11 yr 11 moFDA
11,077,189Mar 14, 2039in 13 yrFDA
11,992,529Mar 14, 2039in 13 yrFDA

Taxonomy and ontology

11 terms

center

Center for Drug Evaluation and Research

center · CDER

application pathway

Biologics License Application

blaNumber · BLA

license type

351(k) Interchangeable

blaType · 351(k) Interchangeable

application pathway

Section 351(k) Biosimilar or Interchangeable

blaType · 351(k)

product role

Interchangeable Biologic

blaType · Interchangeable

marketing status

Prescription

marketingStatus · Rx

licensure status

Licensed

licensure · Licensed

route

Intravenous

routeOfAdministration · Intravenous

dosage form

Injection

dosageForm · Injection

source kind

Monthly Download

sourceKind · monthly_download

  • Food and Drug Administrationparent ofCenter for Drug Evaluation and Research
  • Food and Drug Administrationsource forMonthly Download
  • Biologics License Applicationparent ofSection 351(a) Biologic
  • Biologics License Applicationparent ofSection 351(k) Biosimilar or Interchangeable
  • Section 351(k) Biosimilar or Interchangeablemaps to351(k) Biosimilar
  • Section 351(k) Biosimilar or Interchangeablemaps to351(k) Interchangeable

Source provenance

Source kind · Monthly download
Checked May 28, 2026
FDA release · April 2026
Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.