Malaysian guidelines for biosimilars

The Ministry of Health Malaysia through the National Pharmaceutical Control Bureau (NPCB), which was set up in 1985, is the Malaysian authority that assures the quality of medicines in the country.

The NPCB is in charge of ensuring that all pharmaceutical and health products in the Malaysian market are of quality, safe and efficacious, regulated according to relevant legislations and used rationally.

In Malaysia, a biosimilar is defined 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’.

An abbreviated pathway for biosimilars was established and guidelines for biosimilars were published by the NPCB in July 2008.

Overarching guidelines
These guidelines cover all biosimilar products:

Guidance document and guidelines for registration of biosimilars in Malaysia
30 July 2008
portal.bpfk.gov.my/index.cfm?menuid=46&parentid=15

This document should be read in conjunction with the relevant sections of the Control of Drugs and Cosmetic Regulations 1984 (CDCR 1984) and the relevant sections of other applicable NPCB guidance documents.

The guidance document applies to biological drugs that contain well-characterised proteins, but does not cover complex biological, such as blood-derived products, vaccines, immunologicals, gene/cell therapy products, etc.

Approval of a product through the biosimilar pathway is not an indication that the biosimilar may be automatically substituted.