New Zealand IBD charity releases position statement on biosimilars

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New Zealand IBD charity releases position statement on biosimilars

Biosimilares/General | Posted 17/07/2020 0 Post your comment

The charity Crohn’s and Colitis New Zealand has released a position statement on biosimilars, although there are not yet any biosimilars for inflammatory bowel disease (IBD) on the market in New Zealand.

Biological drugs are the mainstay of treatment for IBD, which includes Crohn’s disease and ulcerative colitis. There are estimated to be over 11 million people worldwide living with IBD, making more affordable versions of biological drugs an important option for many.

Commonly used biological drugs include infliximab (brand name Remicade) and adalimumab (brand name Humira), both of which are monoclonal antibodies that target the inflammatory molecule tumour necrosis factor-alpha (TNF-α).

There are currently no biosimilars for IBD on the market on New Zealand, which has one of the highest rates of IBD in the world.

In preparation for biosimilars entering the market, the Crohn’s and Colitis New Zealand Charitable Trust has released a position statement on biosimilars.

The statement was released on 9 July 2020 and explains that biological drugs have complex structures that are impossible to duplicate exactly. It also explains that biosimilars are ‘probably just as effective as the original medications’ and that the decision to switch to a biosimilar drug is usually motivated by cost.

The charity’s full position on biologicals is:

Non-medical switching from a biological to a biosimilar is not recommended.
Any switch from an originator biological to its biosimilar should only be done with the agreement of the patient and their physician.
Any widescale plan for switching from an originator drug to a biosimilar should be accompanied by a national programme of patient monitoring for loss of efficacy and adverse drug reactions.
Any cost savings from the introduction of biosimilars should be used to fund additional medications to treat IBD.

The statement shares similarities with that of Crohn’s and Colitis Canada, which issued their position statement on biosimilars in September 2019 [1]. A more detailed statement was issued by the Swiss Society of Gastroenterology, covering also the regulatory process, extrapolation of indications and prescriptions [2].

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References
1. GaBI Online - Generics and Biosimilars Initiative. Canadian IBD charity updates biosimilar position statement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Biosimilars/General/Canadian-IBD-charity-updates-biosimilar-position-statement
2. GaBI Online - Generics and Biosimilars Initiative. Swiss position statement on the use of biosimilars in IBD [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Biosimilars/General/Swiss-position-statement-on-the-use-of-biosimilars-in-IBD

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Source: Crohn’s and Colitis New Zealand Charitable Trust