Registering a biologic or biosimilar in Malaysia

You are registering a biologic new to Malaysia, or a biosimilar of a reference product.

Your route into Malaysia.

The DRGD door(s) for this product class, on the same month axis the register uses — how long each takes and what it asks. Neutral facts; the timing call for a specific molecule is the read.

012mo24mo36mo

Biosimilar evaluation

Generic · biologic · prescription

RM5,000 processing + RM20,000 GMP inspection (foreign site); capital-heavy

18–30 months

Full biologic (new drug) evaluation

New · biologic · prescription

RM5,000 processing + RM20,000 GMP inspection (foreign site); capital-heavy, cold-chain

24–36 months

What the pathway asks.

Comparability / similarity exercise
Clinical confirmation
PIC/S GMP certification
Local product registration holder
Full quality/safety/efficacy dossier
Comparability & immunogenicity data

Where it gets hard

The register makes the pathway legible. These parts don't self-serve.

A comparability / biosimilarity exercise against the reference product
Cold-chain and stability data across the full supply route
Facility PIC/S GMP for biologics manufacture and fill-finish

Talk to our consultantsWe run the dossier, the GMP path and the holder appointment with you.