NICE recommends infliximab biosimilars ahead of Remicade

June 25, 2015 9:52 AM

NICE is recommending biosimilar versions of Remicade and says that the new and cheaper treatments should be used ahead of the original patented medicine, reports PMLiVE.

Inflectra & Remsima are both the biosimilar versions of Janssen/MSD’s Remicade (infliximab). The product which is developed by Celltrion is being sold by Hospira and Napp in the UK.

Hospira’s product Inflectra is now in draft guidance NICE-recommended for both first and second line approaches in rheumatoid arthritis. Napp’s Remsima has also passed NICE’s early-stage cost-effectiveness criteria for the same licence.

This is not the first time NICE has recommended a biosimilar, and in fact Inflectra has 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 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: “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The NICE spokesman says that this also means the draft guidance states: “That treatment should be started with the least expensive drug,” – ie, that biosimilar versions should be used ahead of Remicade in order to help the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.

Source: PMLiVE

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