MALAYSIAL01FD01
Trastuzumab
Antineoplastic and Immunomodulating Agents · Entry into the Malaysia market
Two clocks — the door and the route
The door is closing while your clock runs — you would register into a crowd, not an opening.
Door state: closing · fill 1.5 new makers/yr · registration route ~30 months. By the time the route completes, more makers have filled in. Verify the fill rate and route against current NPRA data before reading this as a stop.
Market gate — is the door open?
Door: Closing
OpennessTight · 31/100 — how contestable the market is, not whether you'll win
Makers4 registered makers on NPRA
Fill rate~1.5 new makers/yr registering (last 2 years)
Market sizeOur open sizing isn't published for this molecule yet — we'd rather show nothing than borrow a number.
Pathway gate — can I get in, how, how long?
Biosimilar evaluation
~18–30months
Comparability / similarity exercise
Clinical confirmation
PIC/S GMP certification
Local product registration holder
FeesRM5,000 processing + RM20,000 GMP inspection (foreign site); capital-heavy
NPRA DRGD 6th ed., biosimilar guidelinedirectional estimate — verify
Basis — 4 registration(s), mostly prescription