Position Statement On Biosimilars

Crohn’s and Colitis New Zealand Charitable Trust is a national organisation whose mission is to support people with Crohn’s disease and ulcerative colitis. Its Board of Trustees has approved a position statement regarding medications known as “biosimilars”.

Unlike a generic drug which has the exact same molecular structure as the original brand-name medication, a biosimilar is not an exact copy The reason for this is that medications known as “biologics” such as infliximab and adalimumab are derived from living cells and have very complex molecular structures that are impossible to duplicate exactly.

While biosimilars are probably just as effective as the original medications, there is concern about switching someone who is doing well to another medication that is not exactly the same. As biosimilars are generally less expensive than the original medication, the decision to switch is usually based on the cost of the medication, rather than its efficacy.

Currently, in New Zealand, there are no biosimilars being used for Inflammatory Bowel Disease, although it is expected that they will be introduced in the future.POSITION STATEMENT ON BIOSIMILARS

Crohn’s and Colitis New Zealand Charitable Trust is an organisation providing support to the over 20,000 people in New Zealand with Inflammatory Bowel Disease (Crohn’s disease and ulcerative colitis). New Zealand has one of the highest rates of these diseases in the world.

Biosimilars are biologic therapies that are copies of currently approved biological medications (called “originator drugs”) used to treat these diseases.

Biosimilars are considered to be as safe and as effective as the originator drugs, but, unlike generic medications, they are not identical.

CCNZ recognises that biosimilars may be considered in the future in New Zealand for the treatment of IBD due to budgetary constraints as these medications are usually less expensive than the originator drugs.CCNZ has the following position on biologics:

Non-medical switching from a biological medication to a biosimilar is not recommended.

Any switch from an originator biological medication to its biosimilar should be done only with the agreement of both the patient and doctor.

Any widescale plan for switching from an originator drug to a biosimilar should be accompanied by a national program of close patient monitoring, specifically monitoring for loss of efficacy and adverse drug reactions.

Any cost savings from the introduction of biosimilars for the treatment of inflammatory bowel disease should be earmarked for the funding of additional medications to treat Crohn’s disease and ulcerative colitis.