Ten years after the first etanercept biosimilar entered the European market, biosimilars have helped expand access to biologic therapies for millions of patients

The introduction of copycat versions of expensive biologic medicines has transformed treatment access for millions of Europeans living with immune-mediated inflammatory diseases, as cost savings from biosimilar competition are increasingly being reinvested into broader patient care.

Conditions such as rheumatoid arthritis, psoriasis, Crohn’s disease and ulcerative colitis frequently require long-term management to prevent disease progression and disability. For many years, the biologic therapies that most effectively addressed these conditions remained out of reach for large numbers of patients because of their cost.

That picture has changed substantially over the past decade. According to a recent report led by KU Leuven under the MABEL project, off-patent biologics and biosimilars now account for approximately 70 per cent of the volume of biologic medicines used across Europe, collectively treating an estimated 12 to 15 million patients annually.

The shift traces back to a single regulatory milestone: the approval of the first etanercept biosimilar in Europe ten years ago. That entry opened the market to price competition in a therapeutic area previously dominated by high-cost originator products. Biosimilars have since become an established feature of immunological care across the continent.