Request that the FDA withdraw approval for Ocrevus Zunovo for the PPMS indication, as the FDAs approval of Ocrevus Zunovo for PPMS was based on (at least in part) the prior approval that established substantial evidence of effectiveness for Ocrevus (intravenously administered ocrelizumab (IV OCR), BLA 761053) since the FDAs own documentation of intravenously | Federal Regulations · Congress.wiki

Nonrulemaking

FDA

Open for Comments

FDA-2026-P-4104

Request that the FDA withdraw approval for Ocrevus Zunovo for the PPMS indication, as the FDAs approval of Ocrevus Zunovo for PPMS was based on (at least in part) the prior approval that established substantial evidence of effectiveness for Ocrevus (intravenously administered ocrelizumab (IV OCR), BLA 761053) since the FDAs own documentation of intravenously

Documents

Comments

Description

OPEN

Key Dates

Comment Period OpensApr 15, 2026

Documents

Type	Title	Posted	Comments	Status
Supporting Material	Attachment 3 - “Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products, Guidance for Industry, Draft Guidance” (December 2019): attached as PDF	Apr 15, 2026	--

Keywords

CDER

Citizen Petition

withdraw approval for Ocrevus Zunovo for

the PPMS indication, as the FDAs approval

of Ocrevus Zunovo for PPMS was based on

(at least in part) the prior approval that

established substantial evidence of

effectiveness for Ocrevus (intravenously

Data from Regulations.gov