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First biosimilar mAb gets the nod in EU

Approval for Hospira's version of J&J's Remicade has global implications

Hospira and partner Celltrion have become the first companies to gain approval in the EU for a biosimilar monoclonal antibody (mAb), winning a green light for their infliximab-based products. 

The biosimilar - which will be sold as Inflectra by Hospira and Remsima by Celltrion - will compete in the EU market with the original infliximab brand Remicade from Johnson & Johnson.

Remicade is approved to treat rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis and last year racked up European sales of over $2bn.

The landmark decision has global implications as it represents the first time that a biosimilar has been approved in an established world market, opening the door to lower cost competition to monoclonal antibodies with sales in the order of tens of billions of dollars.

Inflectra was originally developed by South Korea-based Celltrion and licensed by Hospira under the terms of a 2009 agreement involving eight mAb biosimilars. The new drug will be launched onto the EU market "at the earliest opportunity taking into account any relevant patent protection", according to Hospira.

The main obstacle for an imminent launch is that Remicade's main EU patent has been extended until February 2015, which will delay the launch of Inflectra and Remsima in the top five European markets (France, Germany, Italy, Spain and the UK), according to Decision Resources.

Hospira has suggested that the launch of biosimilar mAbs in Europe has the potential to deliver savings of up to €20bn (around $27bn) by 2020, with the greatest savings coming from France, Germany and the UK.

The biosimilar was backed by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in June based on the results of a phase III trial in which Inflectra met the primary measure of therapeutic equivalence to Remicade in the treatment of rheumatoid arthritis patients.

Meanwhile, Celltrion said today it has filed for approval of biosimilar infliximab as Remsima in Japan, where Remicade sales are around $1bn. In Japan the drug will be co-marketed by Celltrion's development partner Nippon Kayaku. 

In the US - where Hospira has commercialisation rights - it is expected to reach the market by 2015.

11th September 2013

From: Sales, Regulatory



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