Skip to main content

Official Malaysian Government Website

Text size

Display

Reading

+603-7883 5400

BM EN

Ministry of Health Malaysia National Pharmaceutical Regulatory Agency

PRODUCT CATEGORIES

Biologic
Combination Products
Cosmetic Products
Generic Medicines
Natural Products
Health Supplement
New Chemical Entity (NCE)
Veterinary Medicine

REGULATORY INFORMATION

Basic Regulation
Active Pharmaceutical Ingredients (API)
Bioequivalence and Ethics Committee Inspection
Compliance and Licensing
Good Clinical Practice (GCP) & Good Laboratory Practice (GLP)
Laboratory & Quality Control
Medicinal Gases
Pharmacovigilance
Phase I Unit Inspection & Accreditation Programme
Surveillance & Complaints

MORE REGULATIONS

Industry Main Page
Drug Registration Guidance Documents (DRGD)
Helpdesk Enquiry
In House Application
Market Sampling
QUEST Updates and Announcements
Medicine Shortage & Discontinuation Reporting
Recent Updates

QUEST5 Submit, track and manage registrations and licences online.

Reporting

Reporting on Notified Cosmetic Products
Reporting Side Effects to Medicines (ConSERF) or Vaccines (AEFI)
Quality Reporting on Registered Product

Consumer Information

Consumer Main Page
Products Search
Technical Evaluation Summary
e-Brochures
Vaccine Lot Release : Lot Release Certificate
Plasma Products Lot Release : Lot Release Certificate
Online Public Engagement
Contact Us
Lot Release for Covid-19 Vaccines

Safety Information

Cancellation of Registered Complementary & Alternative Product
Cancellation of Notified Cosmetic Products
Adulterated Products ( Unregistered )
Vaccine Lot Release : Notification of Non Compliance
Plasma Products Lot Release : Notification of Non Compliance
Product Recall

Health Professionals

Health Professionals

Health Professionals Main Page
Safety Alerts
Direct Healthcare Professional Communications (DHPCs)
#MedSafetyWeek
Reporting ADR / AEFI
Quality Reporting
MADRAC Bulletin
REAKSI Drug Safety News
Press Releases on AEFIs of COVID-19 Vaccines
Summary Reports on AEFIs of COVID-19 Vaccines

General Information

Announcement
Press Release
Circulars & Directives
Training & Seminars
Research & Development
E-labelling

New Products / Indication

New Products Approved
Additional Indications Approved
New Chemical Entities
Biosimilars Approved
Surface Disinfectants Approved
Orphan Medicines Approved

QUEST List of Manufacturers / Wholesalers / Importers

QUEST 3+ License Search
List of Cosmetic Manufacturers in QUEST System

Annual Reports

NPRA Annual Reports
National Centre for Adverse Drug Reaction Monitoring Annual Report

Safety Information

Cancellation of Registered Complementary & Alternative Product
Cancellation of Notified Cosmetic Products
Adulterated Products ( Unregistered )
Vaccine Lot Release : Notification of Non Compliance
Plasma Products Lot Release : Notification of Non Compliance
Product Recall

Newsletter

Berita Ubat-ubatan
e-Brochures
Coffee Table Book

NPRA INFORMATION

Vision, Mission and Objective
Roles and Functions
Organisation Chart
NPRA's Clients Charter
NPRA's Quality Objective
NPRA Obligation
NPRA Quality Policy & MS ISO 9001:2015 Certification Scope
EKSA Bulletin
NPRA Safety Policy
Gallery
Online Public Engagement
Tawaran Iklan

Recognition & International Membership

WHO Collaborating Centre
PIC/S
OECD-GLP-MAD
NPRA Awards & Recognition

Useful Links

Staff Directory
Our Location
Public Enquiry

Drug Control Authority (DCA)

DCA Members
About the DCA
DCA Expert Advisor Panel
DCA News

Malaysian Adverse Drug Reactions Advisory Committee (MADRAC)

MADRAC Introduction
MADRAC Members

Industry

PRODUCT CATEGORIES

Biologic
Combination Products
Cosmetic Products
Generic Medicines
Natural Products
Health Supplement
New Chemical Entity (NCE)
Veterinary Medicine

REGULATORY INFORMATION

Basic Regulation
Active Pharmaceutical Ingredients (API)
Bioequivalence and Ethics Committee Inspection
Compliance and Licensing
Good Clinical Practice (GCP) & Good Laboratory Practice (GLP)
Laboratory & Quality Control
Medicinal Gases
Pharmacovigilance
Phase I Unit Inspection & Accreditation Programme
Surveillance & Complaints

MORE REGULATIONS

Industry Main Page
Drug Registration Guidance Documents (DRGD)
Helpdesk Enquiry
In House Application
Market Sampling
QUEST Updates and Announcements
Medicine Shortage & Discontinuation Reporting
Recent Updates

Consumers

Reporting

Reporting on Notified Cosmetic Products
Reporting Side Effects to Medicines (ConSERF) or Vaccines (AEFI)
Quality Reporting on Registered Product

Consumer Information

Consumer Main Page
Products Search
Technical Evaluation Summary
e-Brochures
Vaccine Lot Release : Lot Release Certificate
Plasma Products Lot Release : Lot Release Certificate
Online Public Engagement
Contact Us
Lot Release for Covid-19 Vaccines

Safety Information

Cancellation of Registered Complementary & Alternative Product
Cancellation of Notified Cosmetic Products
Adulterated Products ( Unregistered )
Vaccine Lot Release : Notification of Non Compliance
Plasma Products Lot Release : Notification of Non Compliance
Product Recall

Health Professionals

Health Professionals

Health Professionals Main Page
Safety Alerts
Direct Healthcare Professional Communications (DHPCs)
#MedSafetyWeek
Reporting ADR / AEFI
Quality Reporting
MADRAC Bulletin
REAKSI Drug Safety News
Press Releases on AEFIs of COVID-19 Vaccines
Summary Reports on AEFIs of COVID-19 Vaccines

Information

General Information

Announcement
Press Release
Circulars & Directives
Training & Seminars
Research & Development
E-labelling

New Products / Indication

New Products Approved
Additional Indications Approved
New Chemical Entities
Biosimilars Approved
Surface Disinfectants Approved
Orphan Medicines Approved

QUEST List of Manufacturers / Wholesalers / Importers

QUEST 3+ License Search
List of Cosmetic Manufacturers in QUEST System

Annual Reports

NPRA Annual Reports
National Centre for Adverse Drug Reaction Monitoring Annual Report

Safety Information

Cancellation of Registered Complementary & Alternative Product
Cancellation of Notified Cosmetic Products
Adulterated Products ( Unregistered )
Vaccine Lot Release : Notification of Non Compliance
Plasma Products Lot Release : Notification of Non Compliance
Product Recall

Newsletter

Berita Ubat-ubatan
e-Brochures
Coffee Table Book

About NPRA

NPRA INFORMATION

Vision, Mission and Objective
Roles and Functions
Organisation Chart
NPRA's Clients Charter
NPRA's Quality Objective
NPRA Obligation
NPRA Quality Policy & MS ISO 9001:2015 Certification Scope
EKSA Bulletin
NPRA Safety Policy
Gallery
Online Public Engagement
Tawaran Iklan

Recognition & International Membership

WHO Collaborating Centre
PIC/S
OECD-GLP-MAD
NPRA Awards & Recognition

Useful Links

Staff Directory
Our Location
Public Enquiry

Drug Control Authority (DCA)

DCA Members
About the DCA
DCA Expert Advisor Panel
DCA News

Malaysian Adverse Drug Reactions Advisory Committee (MADRAC)

MADRAC Introduction
MADRAC Members

English

Biosimilar Approved

Written by Seksyen Biologik · 10 July 2026

Document	Date
Biosimilars Approved	2nd July 2026

Document · PDF · 377 KB

Download Biosimilar Approved

Rate this page

1 out of 5 2 out of 5 3 out of 5 4 out of 5 5 out of 5

Not yet rated

Share Share on Facebook Share on X Share on WhatsApp Share on LinkedIn

Page tools

← All publications

National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia. Lot 36, Jalan Prof. Diraja Ungku Aziz, 46200 Petaling Jaya, Selangor.

+603-7883 5400

Industry

Product Registration
QUEST5
Publications
Helpdesk

Consumers

Consumer Information
Medicine Information (RiMUP)
Lot Release Certificates

Agency

Health Professionals
Newsroom
Privacy Policy
Publications
Events
Contact us
Search

© 2026 National Pharmaceutical Regulatory Agency, Ministry of Health Malaysia.