Biologic Definition & Introduction

Biologic Definition & Introduction

•  Definition:

The term ‘biopharmaceutical' was coined in the 80's to define proteins that were made by recombinant DNA technology [which includes hybridoma technology for monoclonal antibody (mAb) production].

•  Biologic/ Biological product refers to a product whose active substance is made by or derived from a living organism (plant, human, animal or microorganism) and may be produced by biotechnology methods and other cutting-edge technologies.  This product imitates natural biological substances in our bodies such as hormones, enzymes or antibodies.

•  Biological substance is defined as a substance that is produced by or extracted from a biological source and that needs, for its characterization and the determination of its quality , a combination of physicochemical-biological testing together with the production process and its controls.

•  Biopharmaceuticals/ Biologics/ Biological products can also be defined as:

“a protein (including antibodies) or nucleic acid-based pharmaceuticals used for therapeutic, which is produced by means other than direct extraction from a native (non-engineered) biological source”.  This corresponds to the new biotechnology view (that is, by elimination, it is largely restricted to recombinant/ genetically engineered and mAb-based products).

•  The term ‘Biotechnology product' and ‘Biological product' are used to broadly refer to all biopharmaceuticals (by the broad biotechnology view).

Note:

Today, biologics have become inextricably intertwined with biopharmaceuticals, to the point where they are synonymous.  The general consensus is that the term ‘Biologic' and ‘Biopharmaceutical' are interchangeable.

Biologics include a wide range of products such as: vaccines, blood products, monoclonal antibodies (therapeutics), recombinant proteins (including but not limited to insulins, hormones, erythropoetins and other hematopoietic factors), cytokines (including but not limited to interferons, interleukins, colony-stimulating factors, tumour necrosis factors), cell and gene therapy products (CGTPs).  

But does not include:

•  Metabolites from microorganisms; e.g. antibiotics and some hormones;

•  Macromolecules produced by chemical synthesis; e.g. peptides/ oligo-nucleotides produced by chemical synthesis;

•  Whole blood or cellular blood components.

•  For detail on registration of Biologics products, please refer Appendix 3: Guideline on Registration of Biologics.

Note: This document is not intended to apply on the control of genetically modified live organisms designed to be used directly in humans, e.g. live vaccines  

•  Unlike small-molecule generic drugs, exact copies of biologics are impossible to produce because these are large and highly complex molecules produced in living cells. A ‘biosimilar'medicinal product (a short designation for ‘similar biological medicinal product') is considered as a new biological medicinal product developed to be similar in terms of quality, safety and efficacy to an already registered, well established, medicinal product. For details, please refer to Guideline on Registration for Biosimilars in Malaysia.

•  Cell and gene therapy products (CGTPs) is regulated as Biologic products. Unlike biotechnology products which are mostly purified proteins of cells, CGTPs contain living and functional cells. Therefore, CGTP is regulated under a separate framework. For details, please refer to: Guidance Document and Guidelines For Registration of Cell and Gene Therapy (CGTPs).

This document provides information for manufacturers, applicants, healthcare professionals and the general public on legal arrangements in Malaysia for the registration of CGTPs. The implementation of the guideline will be compulsory on 1 January 2021 as stated in the Directive No. 6 Year 2017. Ref: BPFK/PPP/07/25(11)Jld.1: Direktif Untuk Menguatkuasakan Penggunaan Guidance Document And Guideline For Registration Of Cell And Gene Therapy Products (CGTPs), December 2015 Dan Good Tissue Practice Guideline, 2 ND Edition, December 2015).

Biologics

Definition:
The term ‘biopharmaceutical' was coined in the 80's to define proteins that were made by recombinant DNA technology [which includes hybridoma technology for monoclonal antibody (mAb) production].

Biologic/ Biological product refers to a product whose active substance is made by or derived from a living organism (plant, human, animal or microorganism) and may be produced by biotechnology methods and other cutting-edge technologies.  This product imitates natural biological substances in our bodies such as hormones, enzymes or antibodies.

Biological substance is defined as a substance that is produced by or extracted from a biological source and that needs, for its characterization and the determination of its quality , a combination of physicochemical-biological testing together with the production process and its controls.

Biopharmaceuticals/ Biologics/ Biological products can also be defined as:
“a protein (including antibodies) or nucleic acid-based pharmaceuticals used for therapeutic, which is produced by means other than direct extraction from a native (non-engineered) biological source”.  This corresponds to the new biotechnology view (that is, by elimination, it is largely restricted to recombinant/ genetically engineered and mAb-based products).

The term ‘Biotechnology product' and ‘Biological product' are used to broadly refer to all biopharmaceuticals (by the broad biotechnology view).

Note:
Today, biologics have become inextricably intertwined with biopharmaceuticals, to the point where they are synonymous.  The general consensus is that the term ‘Biologic' and ‘Biopharmaceutical' are interchangeable.

Biologics include a wide range of products such as: vaccines, blood products, monoclonal antibodies (therapeutics), recombinant proteins (including but not limited to insulins, hormones, erythropoetins and other hematopoietic factors), cytokines (including but not limited to interferons, interleukins, colony-stimulating factors, tumour necrosis factors), cell and gene therapy products (CGTPs).  

But does not include:
•Metabolites from microorganisms; e.g. antibiotics and some hormones;
•Macromolecules produced by chemical synthesis; e.g. peptides/ oligo-nucleotides produced by chemical synthesis;
•Whole blood or cellular blood components.
•For detail on registration of Biologics products, please refer Appendix 3: Guideline on Registration of Biologics.

Note: This document is not intended to apply on the control of genetically modified live organisms designed to be used directly in humans, e.g. live vaccines  

Unlike small-molecule generic drugs, exact copies of biologics are impossible to produce because these are large and highly complex molecules produced in living cells. A ‘biosimilar'medicinal product (a short designation for ‘similar biological medicinal product') is considered as a new biological medicinal product developed to be similar in terms of quality, safety and efficacy to an already registered, well established, medicinal product. For details, please refer to Guideline on Registration for Biosimilars in Malaysia.

Cell and gene therapy products (CGTPs) is regulated as Biologic products. Unlike biotechnology products which are mostly purified proteins of cells, CGTPs contain living and functional cells. Therefore, CGTP is regulated under a separate framework. For details, please refer to: Guidance Document and Guidelines For Registration of Cell and Gene Therapy (CGTPs).

This document provides information for manufacturers, applicants, healthcare professionals and the general public on legal arrangements in Malaysia for the registration of CGTPs. The implementation of the guideline will be compulsory on 1 January 2021 as stated in the Directive No. 6 Year 2017. Ref: BPFK/PPP/07/25(11)Jld.1: Direktif Untuk Menguatkuasakan Penggunaan Guidance Document And Guideline For Registration Of Cell And Gene Therapy Products (CGTPs), December 2015 Dan Good Tissue Practice Guideline, 2 ND Edition, December 2015).

Recent Updates, Directives & Circulars


  • Recent Updates for Guidelines, Circulars, Directives, FAQ & Announcements for Biologics
  • Directives & Circulars Related to Biologics

Product Registration Process

Step I : Preparation

Product classification, Token Configuration, Payment Mode, Patent and Data Exclusivity status and Ensure key documents availability.

Pre-submission of Application (Preparation)

Step I : Preparation

Step II : Submission

Key-in, upload documents and submit your application (Part I, Part II, Part III & Part IV)

Product Validation, Part I, Part II, Part III & Part IV

Step 2 : Submission

Step 3 : Regulatory Outcome

Evaluation of Application & Drug Control Authority (DCA) decision.

Evaluation of Application & Drug Control Authority (DCA) decision.

Step 3 : Regulatory Outcome

Step 4 : Post-registration Process

Maintenance of Registration, Withdrawal of Product Registration, Amendment to the particulars of the product, Post marketing activities

Maintenance of Registration, Withdrawal of Product Registration, Amendment to the particulars of the product, Post marketing activities

Step 4 : Post-registration Process

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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