Infliximab & Biosimilars

What else should I know about INFLIXIMAB & BIOSIMILARS?

You have been given this patient information leaflet as you are currently being treated with a drug called infliximab for Juvenile rheumatoid arthritis / Ankylosing spondylitis / Psoriatic arthritis / Psoriasis / Ulcerative colitis / Crohn's disease /___________________ [circle as appropriate].

The brand name that the makers of infliximab give their medicine is Remicade^®. Remicade^® belongs to a group of drugs called "biologic medicines".  Biologic medicines like Remicade^® are initially manufactured by a single pharmaceutical company. However, as the patent for Remicade^® has expired, other versions of infliximab such as Remsima^®, have become available at a much lower cost. This is called a biosimilar.

The cost of Remicade is _________and the cost of Remsima is ____________.  ( please check with your healthcare provider)

What is a biosimilar?

Copies of simple medicines that are easy to reproduce such as paracetamol are known as "generic" medicines. Biologic medicines, like Remicade^®, are more complicated to produce and to copy. A copy of a biologic medicine is called a "biosimilar". This means that the medicine produced will be "similar" to the original biologic.

There is now a "biosimilar" version of Remicade^® available in the Singapore. It is sold by a different company and has a different brand name i.e. Remsima; however they both contain the same version of infliximab.

Does Remsima work as well as Remicade^®?

Remsima has been thoroughly tested and analysed. Research has shown that it works as well and is as safe to be used. As Remsima is very similar in structure and has the same biological activity as Remicade, not all clinical studies performed in Remicade® need to be repeated for Remsima; instead its studies aim to show that there are no clinically meaningful differences between Remicade® and Remsima.

Remsima has been used successfully in other hospitals in the UK and Europe and is approved by the European Medicines Agency, UK Medicines Healthcare Regulatory Authority and Singapore Health Sciences Authority (HSA).

We expect patients using Remsima to have the same response as Remicade®. Unfortunately, all drugs may stop being effective at some point in time. This is no more likely to happen on Remsima than it is on Remicade^®. However, any decision on switching should be taken by your doctor in consultation with you.

What happens if I change to a biosimilar but I have side effects?

We do not expect any patients to experience problems as a result of switching to the biosimilar infliximab. However if you do decide to switch to the biosimilar and you do experience any problems you will need to discuss this with your doctor.

Are there available studies supporting paediatric indications?

Yes.  Studies have shown that it is safe and effective in paediatric clinical trials. However, as Remicade^® is the originator product; there will be always be more clinical studies available for Remicade^® than that for Remsima. 

 For questions related to switching from one biological medicine to another, patients should speak to their doctor, pharmacist or specialist nurse.