biosimilar

Introduction

A biological product FDA-approved based on

• similarity to an already-approved biological product (reference product)
• no clinically meaningful differences in terms of safety & effectiveness from the reference product
• only minor differences in clinically inactive components are allowable

Notes

• mechanism(s) of action, route(s) of administration, dosage form(s) & strength(s) must be the same as the reference product
• FDA approval only for the indication(s) approved for the reference product

More general terms

• qualifier

More specific terms

• adalimumab-adbm (Cyltezo)
• adalimumab-atto (Amjevita)
• epoetin-zeta (Silapo, Retacrit)
• etanercept-szzs (Erelzi)
• filgrastim-sndz (Zarxio)
• infliximab-abda (Renflexis)
• infliximab-dyyb (Inflectra, Remisima, CT-P13)

Additional terms

• bioequivalent
• generic drug