1997: First clinical trial with D2E7 (Humira), the first fully human monoclonal antibody approved by the US Food and Drug Administration (FDA)

Nominated by: BIO Deutschland

Organisations in nomination: BASF, Abbott, AbbVie, Cambridge Antibody Technology (now MedImmune)

Diseases linked to the immune system, such as rheumatoid arthritis were very challenging drug targets, with prolonged treatment often bringing serious side effects and limited effectiveness.

Immunotherapeutics were a high priority for the emerging global biotech sector but it was not until 1997 that a clinical trial for rheumatoid arthritis was undertaken – with D2E7, a fully human monoclonal antibody which acted as a TNF-alpha inhibitor.  TNF (tumour necrosis factor) is part of the inflammatory response seen within arthritis and the TNF inhibitor could, for the first time, open up the prospect to reduce the damaging effects and pain of the disease.

BASF Knoll developed, in collaboration with UK biotech SME Cambridge Antibody Technology, the antibody D2E7 and conducted the clinical trial.  The success of it paved the way for development to market of D2E7, leading to the first fully human monoclonal antibody approved by the US Food and Drug Administration (FDA) in 2002, followed by the EU in 2003.

The advent of TNF-alpha-blockers like Humira has revolutionized the treatment of millions of patients suffering from rheumatoid arthritis and other autoimmune disorders such as Crohn’s disease, colitis ulcerosa and psoriasis.  Disease remission has, since the approval of Humira and related drugs, been a realistic goal for many patients rather than containment or management of symptoms.

Humira is now reported as the highest global drug sales in 2020, at US$19.8bn for AbbVie.  Its pathway from trial by BASF to present day followed acquisition of BASF’s pharma business in 2001 by Abbott, which then split into Abbott and AbbVie in 2013.


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