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Hospira's Inflectra approved in Europe

Published on 10/09/13 at 02:14pm
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Hospira has been the first firm to meet the European Commission’s approval for a biosimilar monoclonal antibody therapy with its treatment Inflectra.

The ruling puts Hospira right at the front of the antibody copying queue following the recent CHMP recommendation on biosimilar versions, and will see Inflectra (infliximab) jostling into the marketplace of Janssen’s Remicade which saw European sales of over $2 billion last year.

Inflectra has been approved for the treatment of inflammatory conditions including rheumatoid arthritis (RA), ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis.

Hospira has previously won approvals for other biosimilars in Europe, but this is a first for one of the more complicated antibody blockbusters to be successfully copied, and approved.

Dr Stan Bukofzer, corporate VP and chief medical officer at Hospira, said: "The rigorous scientific review and approval process by the EMA and EC confirms that Inflectra has demonstrated similar quality, efficacy and safety to Remicade.

“For over a decade biologic medicines have been pivotal in treating a range of inflammatory conditions, so the granting of marketing authorisation in Europe is a major milestone for Inflectra, and for the future of biologic therapy."

The firm adds that the introduction of biosimilars mAbs in Europe is expected to deliver savings of up to €20.4 billion by 2020, with the biggest savings predicted in France, Germany and the UK.

Inflectra was approved by the EC following review of safety, efficacy and tolerability data following a Phase III randomised, double-blind trial, where Inflectra met its primary endpoint of therapeutic equivalence to Remicade.

In the study, 73.4% of patients receiving Inflectra achieved a greater than or equal to 20% improvement in RA symptoms after 30 weeks of treatment, compared with 69.7% treated with Remicade. Safety and tolerability data also demonstrated Inflectra's equivalence to Janssen’s antibody.

In 2009 Hospira entered into an agreement with South Korean-based biopharma firm Celltrion, which is developing eight monoclonal antibody biosimilars. Under the terms of the agreement, Hospira obtained the rights to Inflectra in Europe and the US, Canada, Australia and New Zealand.

The firm says Inflectra will be launched throughout Europe at the earliest opportunity taking into account any relevant patent protection. Hospira does not expect to file for US approval through the FDA until 2015.

Brett Wells

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