Mundipharma introduces Remsima (infliximab) in six European countries

To be launched in Germany, Italy, the UK, Netherlands, Belgium and Luxembourg, Remsima is authorised for the treatment of patients with Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis.

The drug has been designed to inhibit tumour necrosis factor alpha (TNF-a), a naturally-occurring protein which promotes inflammation. It has been developed as a biosimilar to the anti-inflammatory drug Remicade and is a powder for concentrate for solution for infusion supplied at 100mg infliximab per vial.

The company has secured rights for Remsima from Celltrion Healthcare Hungary Kft for distribution in the six countries.

Mundipharma International Limited managing director Antony Mattessich said: "Mundipharma is constantly looking to bring new treatments to market that improve patient access to quality healthcare at a price society can afford.

"We believe that Remsima is a product that’s right for the times and look forward to bringing our expertise in pain management to the field of inflammatory autoimmune conditions."

Remsima is licenced by the European Medicines Agency (EMA) for the treatment of chronic, debilitating and often painful inflammatory autoimmune conditions that affect more than seven million people across Europe.

Two randomised, double-blind, multi-centre studies of 54 weeks’ duration with an open label extension to 102 weeks, were conducted to confirm that Remsima is equivalent to the reference product in terms of efficacy and pharmacokinetics and comparable in terms of safety.

The drug is currently in use in Norway and several other European countries.