Categories

Information on Biosimilars

Biosimilar medicines

a highly similar version of an already registered biological medicine

Biological medicines are pharmaceutical products that contain one or more active substances that are derived from living cells or organisms.

How similar is Biosimilar?

Demonstrating high similarity is the foundation of development

As biosimilar medicines are designed and engineered using the latest technology to resemble their reference product as closely as possible,

Development of biological medicines

BIOLOGICAL MEDICINES ARE MEDICINES THAT ARE MADE BY LIVING CELLS OR ORGANISMS

Biological medicines are medicines that are made by living cells or organisms. They are usually made of large proteins that are naturally produced in the human body.

Development of biosimilar medicines

Biosimilar medicines are used to treat the same diseases in the same way

A biosimilar medicine is a highly similar version of an original brand of a biological medicine, brought to market by a different manufacturer once the patent on the original brand expires.

Reassurance of similarity

The aim of the clinical program is to confirm therapeutic equivalence

Biosimilar medicines are required to undergo a tailored clinical program. This is normally a stepwise process, beginning with pharmacokinetic/ pharmacodynamic (PK/PD) studies.

© 2024 Generic and Biosimilar Medicines Association Pty Ltd