Spring Intro 2023

16/02/2023

Head-to-head comparisons with competitor drugs

Typical characteristics:

• Mainly to support marketing and/or pricing • Endpoints deliberately selected to favour test drug • Usually not essential for MA… • …not complete (ph IIIb) or even started (ph IV) at time of MA filing

Test drug (at MA dose)

Active comparator (never placebo)

What you want to show

• Better efficacy than competitor • Better safety than competitor • More cost-effective than competitor • Patients prefer your drug

The Organisation for Professionals in Regulatory Affairs PMS

Ph I

Ph IIa

Ph IIb

Ph III

Ph IIIb/IV

55

Post-marketing surveillance: Safety in clinical use

• ICH GCP • Reg / EC / ICF • Formal protocol • Free drug supplied • Defined population

PMS X

Phase IIIb / IV

The Organisation for Professionals in Regulatory Affairs PMS

Ph I

Ph IIa

Ph IIb

Ph III

Ph IIIb/IV

56