While the current use of anti-tumour necrosis factor (TNF) biologics for certain autoimmune diseases is firmly established, significant resources are still being allocated toward discovering alternate drugs for treating conditions such as rheumatoid arthritis and ulcerative colitis.

With anti-TNF drugs like Humira losing patent protection, generic antibodies have emerged and are penetrating this market. Consequently, new and novel drugs under patent are poised to enjoy a period of premium pricing compared to existing biological treatments.

In 2023, three of the top 10 globally acclaimed drugs targeted autoimmune diseases, notably rheumatoid arthritis, atopic dermatitis and inflammatory bowel disease. These three drugs alone amounted to approximately US$36.9 billion in global sales.

While current on-market biologics can induce effective clinical and quality of life improvements, up to one third of patients are not responsive to treatment due to the adaptability of the immune system , as well as be susceptible to considerable side effects, such as increased risk of serious infection and malignancy.

This represents a medical problem and a commercial opportunity. For example, if a patient can continue with a biological drug for five years, there is a continual need for new drugs to supplant the existing drug over the remaining lifespan of the patient – typically somewhere between 20 and 40 years.

Autoimmune diseases include:

Rheumatoid arthritis (RA) – Perhaps the best known and most prevalent autoimmune disease. In RA, the immune system attacks the lining of the joints and causes inflammation, typically resulting in pain, reduced mobility and loss of dexterity. The condition is chronic, debilitating and progressive.

Inflammatory bowel disease (IBD) – IBD is an inflammatory disease of the GI tract which results in severe diarrhoea, abdominal pain, fatigue, weight loss and potentially life-threatening complications. Types of IBD include ulcerative colitis and Crohn’s disease.