Biosimilars for IBD 

Key points 

  • A biosimilar is a very close copy of an original biological medicine. There is no way to make an exact copy of a biological medicine.
  • There are no differences in efficacy, safety, and the way the medicine works in the body compared to the biological medicine.
  • Biosimilar medicines are available for the biological medicines adalimumab and infliximab. 

What is a biosimilar medicine?

A biosimilar is like a biological medicine that can be used to treat Crohn’s disease and ulcerative colitis. 

A biosimilar is a very close copy of an original biological medicine. Biologics are specially made antibodies, which selectively bind to inflammatory signalling proteins to reduce inflammation. Biologics are currently given through an injection under the skin (subcutaneous) or by an intravenous (IV) infusion that delivers the medication into your veins over time, usually in a clinic.

An exact copy of a biological medicine cannot be made, however studies in patients and in the laboratory have shown that there are no major differences between how a biological medicine works and their biosimilar. 

How do I know a biosimilar medicine is safe? 

All biosimilar medicines on the Pharmaceutical Benefits Scheme (PBS) are approved by the Therapeutic Goods Administration. Rigorous testing is completed, and evidence must show that the biosimilar medicine has no differences in efficacy, safety, and the way the medicine works in the body compared to the biological medicine. 

What if I am prescribed a biosimilar medicine? 

There are no adverse patient outcomes switching from a biologic to a biosimilar. The medicine will be taken in the same way (injection or infusion), you will have the same health benefits and it will cost you the same through the PBS. 

It is important to talk to your healthcare professional team about which medicine is best for you. Your doctor may choose which brand is prescribed for you, otherwise your pharmacist may offer you a choice of brands.

What biosimilar medicines are on the PBS for Crohn’s disease and ulcerative colitis?

In Australia, there are biosimilar medicines for the biological medicines adalimumab and infliximab. 

Biological medicineBiosimilar medicine
Adalimumab (Humira)Amgevita, Hadlima, Hyrimoz, Idacio and Yuflyma
Infliximab (Remicade)Inflectra and Renflexis