Biosimilar Development

Demonstrating
clinical comparability¹

A robust and complex process
ensuring structural and clinical
comparability is used to demonstrate
a biosimilar’s clinical comparability to
the reference product.

Data on pharmacokinetics,
pharmacodynamics, immunogenicity,
safety profile and efficacy are collected.²

Reference Medicine

Biosimilar Medicine

Step 1

Comparative quality studies

Analytical: physical + chemical properties
Functional: biological/pharmacological activity

Step 2

Comparative non-clinical studies

Pharmacodynamic
Toxicology

Step 3

Comparative clinical studies

Pharmacokinetics/pharmacodynamics
Efficacy + safety profile + immunogenicity

Adapted from: EMA, Biosimilars in the EU. 2019.²

Replicating complex biologics^3-7

Developing biosimilars has been made possible due to enormous advances in analytical characterization and development of biologics:

Primary structure⁷

Glycosylation pattern^4,5

Charge profile⁶

Higher-order structure³

These methods contribute to a quality attribute fingerprint of the reference drug.^3-7
Accurate analytics allow assessment of critical quality attributes.

Biosimilars change the drug development paradigm⁸

Biosimilars are assessed for similarity to the reference medicine based upon:⁸

Structure
Biological activity
Efficacy
Safety profile
Immunogenicity profile

Indications already studied in a reference product can also be approved for the biosimilar of that product through a process called “extrapolation”.^1,9

A biosimilar must show no clinically meaningful differences from its reference biologic in terms of safety profile, purity, and potency.¹⁰