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Hospira launches biosimilar monoclonal antibody

Published on 16/02/15 at 03:10pm
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Merck’s Remicade patent is set to expire shortly so Hospira expects to be able to launch in the UK very shortly, a spokesman told Pharmafile

Hospira has won the race to become the first company to launch a biosimilar version of an anti-TNF biologic, after launching its copycat of infliximab in major European markets.

Inflectra (infliximab) is launched today in Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, Netherlands, Spain and Sweden - countries where infliximab is now off-patent.

Merck’s Remicade patent is set to expire shortly, and so Hospira expects to be able to launch in the UK ‘in the next few days or weeks’, Paul Greenland, vice president of biologics at Hospira UK told Pharmafile.

Once the EMA and the EC approve a biosimilar it can be considered to be a therapeutic alternative to an existing biologic drug. Inflectra is a biosimilar medicine to Remicade’s infliximab, and became the first biosimilar monoclonal antibody to be approved by the European Commission in September 2013. It is already available in some central and eastern European countries.

The EMA reviewed Inflectra’s biophysical properties and safety, efficacy and tolerability data from an extensive pre-clinical and clinical trial programme.

This included the results of a Phase III study of 606 patients, which found similar proportions of patients who received Inflectra and Remicade achieved a clinically meaningful improvement in their rheumatoid arthritis symptoms after 30 weeks of treatment, with similar safety and tolerability shown in both groups.

To gear up for the launch of Inflectra in western Europe, Hospira has been in reimbursement discussions with governments and health authorities in the different European countries to negotiate prices, and Greenland says the company expects to be offer Inflectra at around a 30% discount compared to Remicade.

Greenland told Pharmafile the launch was “hugely significant for Hospira and also for the biosimilars industry”. He says: “It’s really important for us to be the first. The market for Remicade in Europe is enormous.

“Remicade sales are in the region of €2 billion a year, and the whole anti-TNF market is worth around €9 billion a year. These drugs have offered patients fantastic therapies but they come at a price. So being able to offer a cheaper alternative will be very welcome.”

In the UK the Department of Health in England has confirmed that NICE will be able to decide to apply the same guidance as original products to “relevant licensed biosimilar products which subsequently appear on the market”.

In practice NICE will not go through a new technology appraisal process for Inflectra as it is available for the same indications as Remicade: rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. Prescribers must use the brand dame, batch number and expiry date for prescriptions where branded and biosimilar versions are available.

Remicade has been authorised in the EU since 1999 and MSD racked up European sales of almost €2 billion in 2013. Hospira says the savings generated by introducing biosimilar competition could save European healthcare systems millions of Euros, with biosimilars expected to produce savings of over €20 billion by 2020.

The announcement comes shortly after Hospira announced it will be acquired by US pharma giant Pfizer in a $17 billion deal, which Greenland described as an ‘excellent strategic fit’.

“To some extent we’re just coming to terms with that as to what the announcement will mean for Hospira UK. For now it’s business as usual. We are planning to just continue doing what we were always planning to do – which is make Inflectra a success and work towards the completion of the acquisition by Pfizer in the second half of 2015.”

Lilian Anekwe

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