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AVTOZMA

Interchangeable Biosimilar

TOCILIZUMAB-ANOH | B761498 | CELLTRION INC

4 products0 Purple Book patents2 biosimilars

Biologic LOEBiosimilar competition

2 approved biosimilars

January 24, 2037(3734 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jan. 24, 2037	Active	Computed
1-Year Interchangeable	Jul. 24, 2026	Expired	Purple Book

Purple Book Patents

No listed patents in Purple Book.

Approved Biosimilars

AvtozmaBLA 761498ICAvtozmaBLA 761498

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

No ANDA patent litigation cases (NOS 835) matched from PACER

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 761498 | 2 presentations

InterchangeableLicensedCDERInjection

Proper Name

tocilizumab-anoh

Applicant

CELLTRION, Inc.

Approval Date

January 24, 2025

Reference Product: Actemra — tocilizumab

Presentations

162MG/0.9ML — Pre-Filled Syringe (Subcutaneous)

162MG/0.9ML — Autoinjector (Subcutaneous)

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Sep 30, 2026	ORIG -1	View Letter (PDF)
Sep 4, 2026	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 80MG/4ML(20MG/ML)

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INJECTABLE;IV (INFUSION) | Approved: 2026-01-21 00:00:00

No patent or exclusivity listings for this strength.

#002 — 200MG/10ML(20MG/ML)

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INJECTABLE;IV (INFUSION) | Approved: 2026-01-21 00:00:00

#003 — 400MG/20ML(20MG/ML)

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INJECTABLE;IV (INFUSION) | Approved: 2026-01-21 00:00:00

#004 — 162MG/20ML(20MG/ML)

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INJECTABLE;SUBCUTANEOUS | Approved: 2026-01-21 00:00:00