NICE is recommending two new biosimilar versions of one of the world’s biggest selling drugs and says that these new and cheaper treatments should be used ahead of the original patented medicine.
Inflectra and Remsima (infliximab), manufactured by Celltrion and distributed by several different firms in Europe, is a biosimilar version of Janssen/MSD’s Remicade (infliximab) and makes more than $8bn a year in sales.
The drugs gained European approval earlier this year as a biologic copy of the original treatment, and is now in draft guidance NICE-recommended for both first and second line approaches in rheumatoid arthritis.
This is not the first time NICE has recommended a biosimilar, and in fact Inflectra and Remsima have been recommended by the Institute for treating moderately to severely active ulcerative colitis after the failure of conventional therapy.
But this is still a new area for NICE as there are few biosimilars currently on the market.
NICE told PMLiVE that neither Hospira nor Napp, which distribute the medicines in the UK, have had to submit data for their drugs to the watchdog, as NICE has used previous information from Remicade’s original application.
A spokesman for NICE said: “The Department of Health in England has confirmed that a technology appraisal remit referred to NICE enables NICE to decide to apply the same remit, and the resulting guidance, to relevant licensed biosimilar products which subsequently appear on the market.
“As biosimilars are deemed to be identical to the reference product, companies are not asked to make new applications for the drug’s appraisal by NICE.”
This also means that as regulators have deemed infliximab ‘bioequivalent’ to the originator product (ie, Remicade), NICE is not assessing the treatment as being new, but will however take into consideration the lower price.
Remicade currently costs £419 for a 100ml vial while both versions of the biosimilar infliximab will cost around 10% less at £377, according to NICE.
The NICE spokesman says that this also means the draft guidance states: “That treatment should be started with the least expensive drug,” – ie, that biosimilar versions should be used ahead of Remicade in order to help the NHS save money.
But there still remains questions over just how strong uptake will be of these new drugs, which are an unknown entity to most doctors. And according to a position paper published by the European League Against Rheumatism (EULAR) this month, patients are also anxious about being treated with biosimilar drugs and need access to clear information about trial data to allay their fears.
Nonetheless, if NICE does recommend the biosimilar versions in its final version of this guidance then the NHS in England will be duty-bound to use them ahead of Remicade under new formulary rules.
For now the decision is still subject to consultation, with final NICE guidance expected to be published in October.