Table 1 Key attributes of selected disease area archetypes; considers marketed mAb profiles only

1

RA/IBD

mAbs exhibit sufficient tolerability to allow unsupervised administration outside of a controlled healthcare environment^a

Predominantly SC formulations for self-administration

Low dosing volumes (below 2 mL)

Ready-to-use PFS & autoinjector/pen devices

Several mAbs & other biologics with different & overlapping indications available

A number of mAbs & other biologics also used in other indications

Biosimilars for some mAbs & other biologics available

2

MS

mAb-dependent safety profiles; unsupervised and supervised administration outside of a controlled healthcare environment^a

Predominantly IV formulations for HCP-assisted administration

1 mAb^b with SC formulations for self-administration (dosing volume of 0.4 mL; ready-to-use PFS & autoinjector device)

Few mAbs with overlapping indications

Biosimilars for other biologics available

No mAb biosimilar marketed

3

ONC

mAb-dependent safety profiles; currently no unsupervised administration outside of a controlled healthcare environment

Predominantly IV formulations for HCP-assisted administration

4 mAbs^c with high-volume SC formulations for HCP-assisted administration (volumes of 5 to 15 mL; vial presentations)

1 SC mAb FDC^d

1 IV mAb FDC^e

A variety mAbs with different & overlapping indications available

Biosimilars for some mAbs available