Mundipharma launches monoclonal antibody Remsima in six European markets

Privately-held UK-based drugmaker Mundipharma International is launching Remsima (infliximab) this month in Germany, Italy, UK, Netherlands, Belgium and Luxembourg following expiry of the relevant patents and Supplementary Protection Certificates.

Remsima is the first authorized biosimilar monoclonal antibody and is licenced by the European Medicines Agency (EMA) for the treatment of chronic, debilitating and often painful inflammatory autoimmune conditions that affect over seven million people across Europe. Like the reference product, Remsima is authorized for the treatment of patients with Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis. It works by inhibiting tumour necrosis factor alpha (TNF-α), a naturally-occurring protein which promotes inflammation.

Following an EMA evaluation, Remsima has been found to be comparable to the reference product in terms of safety, efficacy and quality. It is already available in a number of European countries including Norway.