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Biosimilar pharmaceuticals

Infliximab biosimilars to launch in the UK as innovator product reaches patent expiry

Biosimilar monoclonal antibody versions of Janssen Biologics’s Remicade — a medicine that contains infliximab and is used for a variety of inflammatory conditions — will be launched in the UK as patent protection for the innovator product comes to an end.

Napp Pharmaceuticals will launch Remsima in the UK on 25 February 2015, after the patent for Remicade expires on 24 February 2015. Napp has the exclusive rights to distribute Remsima in the UK, although the marketing authorisation holder is Celltrion Healthcare Hungary.

Remsina has already been launched in other European countries such as Norway, Portugal and Ireland, says a Napp spokesperson.

Hospira, which is marketing its own biosimilar version Inflectra, says it plans to launch the product in the UK “in the next few weeks”. The product is now available in 24 European countries including Spain, Germany, Italy and France.

The two products were given marketing authorisation to treat inflammatory conditions by the European Medicines Agency (EMA) in September 2013.

The products have been gradually appearing on European markets as the patent expires on the branded product Remicade — an infusion treatment that has been available in the European Union since 1999. The patent expiry date is different in each country.

Both Remsima and Inflectra are authorised for the same indications as Remicade, covering a range of diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis, the EMA says.

Hospira says the introduction of Inflectra and other biosimilar products to the market will increase competition and has the potential to save EU health systems more than €20bn by 2020.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20067917

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