PARIS, Jan 27 (APM) - France's Official Journal (JO) on Tuesday set out the prices for calculating the reference price of biosimilars of Merck Sharp & Dohme’s anti-TNF Remicade (infliximab) - Servier subsidiary Biogaran’s Remsima and Hospira’s Inflectra.

They are equal to that of Remicade, at 434.40 euros for a 20 ml vial. The prices of the reference drug were cut by 10% on November 1 2014 (APMMA 40180).

The French economic committee for health products (CEPS) presented its policy concerning price setting in October 2014, saying it would lower the price of the reference drug and align the prices of the biosimilars with this (new) to allow competition to play out in full among the various products concerned by hospital calls for tender (APMMA 40135).

Biogaran announced plans to launch its Remicade biosimilar in February (APMMA 40796).

The reference price is equal to the to the before-tax selling price declared by the relevant pharma company to which VAT should be added.

Furthermore, the notice published in the JO lowers the prices for the reference price and the price at which hospital pharmacists can dispense LFB blood-derived products Wilstart (factor VIII+Willebrand factor) and Wilfactin (Willebrand factor) in 10 ml vials, and sets out the price for the reference price of two Wilfactin product line extensions.

According to APM's calculations, as of February 1, the prices of Wilstart, a drug used in the initial von Willebrand disease treatment phase, will fall 10% to 1,116 euros per 5 ml vial. On the same date, the price of Wilfactin in a 10 ml vial will fall by 5% to 1,016.50 euros.

In parallel, prices to calculate the reference price of Wilfactin are set at 508.25 euros for the 5 ml vial and at 2,033 euros for the 20 ml vial.

As of February 15, another notice lowers by 40% the price at which hospital pharmacists can dispense GlaxoSmithKline’s treatment for pulmonary arterial hypertension (PAH) Flolan (epoprostenol) to out-patients and the price used to calculate the reference price of the product. As of February 15, these prices will be 37.55 euros for a vial at 0.5 mg and 43.61 euros for a vial at 1.5 mg.

An order published in Tuesday’s JO has registered Remicade reimbursement for a three-year period within the framework of a temporary use recommendation (RTU) granted in 2014 in Takayasu arteritis that is refractory to conventional treatments (APMMA 40039). This is a rare inflammatory disease that affects some one hundred patients in France.

An order has also approved Lucane Pharma’s TB treatment Granupas (para-aminosalicylic acid) for use in hospitals or healthcare institutions and various public services in part of its indications. The drug that obtained a centralised European marketing authorisation (AMM) in April 2014 will be reimbursed “in combination with other drugs in the treatment of multi-resistant tuberculosis in adults and the paediatric population aged 28 days and over, where the use of another effective treatment regimen is not possible for reasons of resistance or lack of tolerability”.

This order also includes the approval for use in hospitals or healthcare institutions of several product line extensions. In particular, this involves Merck Sharp & Dohme’s antifungal Noxafil (posaconazole) in 100 mg tablets; until now, the product was only available in a form for injection.

Sanofi’s antibiotic for injection Fosfocine (fosfomycin) at doses of 1 g and 4 g is also back on the list of reimbursed products, following the repeal of its marketing authorisations in 2011.

(Journal officiel of January 27, texts 17, 18, 79 & 80)

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