First biosimilar launches in Europe for inflammatory conditions

The first biosimilar monoclonal antibody for inflammatory conditions has been launched into major European markets.

Infliximab (Inflectra, Hospira) is a biosimilar – or copycat – biopharmaceutical drug that has the same active properties as the established Remicade brand (which is losing its patency) by co-owning pharma giants Johnson & Johnson’s drug unit Janssen and Merck.

Infliximab is licensed for the treatment of inflammatory conditions including rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, adult and paediatric ulcerative colitis and plaque psoriasis.

Infliximab is a cornerstone treatment for many inflammatory diseases, with over 15 years’ worth of clinical data and experience. Its biosimilar version now makes it the first biosimilar monoclonal antibody to be approved by the European Commission (EC).

Infliximab has been authorised in the EU since 1999, and as in this case, a biosimilar developed in-line with EU requirements can be considered a therapeutic alternative to an existing biologic.

Paul Greenland who is vice president of the biologics unit at Hospira, says: “Inflectra has already been launched in Central and Eastern Europe, and some smaller Western European markets due to earlier patent expiry, and has already been prescribed to treat patients in all its licensed indications.

“We are delighted that the remaining European countries, including many of the major EU countries, will now benefit from the availability of Inflectra.”

Infliximab received its licence from the EC in September 2013, following adoption of the EMA Committee for Medicinal Products for Human Use (CHMP) positive recommendation for granting marketing authorisation.

In a Phase III randomised, double-blind study involving 606 patients, the biosimilar met its primary endpoint of therapeutic equivalence to infliximab.

In this study 73.4% of patients receiving the biosimilar achieved a greater than or equal to 20% improvement in RA symptoms after 30 weeks of treatment, compared with 69.7% treated with infliximab.

Comparable safety and tolerability data also demonstrated the biosimilar version’s equivalence to infliximab. There were no marked differences in the immunogenicity profile of the two products up to 54 weeks, and the impact of anti-drug antibodies on efficacy and safety was comparable.

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