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POHERDY

Interchangeable Biosimilar

PERTUZUMAB-DPZB | B761450 | SHANGHAI HENLIUS BIOTECH

1 product0 Purple Book patents1 biosimilar

Biologic LOEBiosimilar competition

1 approved biosimilar

November 13, 2037(4151 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Nov. 13, 2037	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Approved Biosimilars

PoherdyBLA 761450IC

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
GENENTECH, INC. et al v. SHANGHAI HENLIUS BIOTECH, INC. et al 2:2025cv14648 24 patentspertuzumab	D.N.J.	2025-08-14	Terminated 2026-01-30	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 761450

InterchangeableLicensedCDERInjection

Proper Name

pertuzumab-dpzb

Applicant

Shanghai Henlius Biotech, Inc.

Approval Date

13-Nov-25

Reference Product: Perjeta — pertuzumab

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 17, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 420MG/14ML(30MG/ML)

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INJECTABLE;INTRAVENOUS | Approved: 2025-11-13 00:00:00

No patent or exclusivity listings for this strength.