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Tumor Necrosis Factor TNF Products - Biotech, Pharma and Life Science Channel

22:07 EDT 19th May 2013 | BioPortfolio

Tumor Necrosis Factor (TNF) and TNF receptor antagonists and agonists used to treat TNF-mediated inflammatory diseases such as rheumatoid arthritis or to treat cancer.

TNF blockers are the commercially most successful single-target group of biologic therapies. 2008 sales of the four approved brands were US$ 16.35 bln with double digit growth rates due to indication expansion and new market entrants. Abbott’s fully human antibody Humira recorded 2008 sales growth of 48 % over the previous year which may explain why competitors with the established brands Enbrel and Remicade also have fully human anti-TNF antibodies in their pipeline. Forthcoming patent expiries also may have encouraged to develop next generation anti-TNF antibodies. Clinical indications approved for therapy with TNF blockers include rheumatoid arthritis(RA) and juvenile RA, ankylosing spondylitis, psoriatic arthritis, psoriasis in adults and in children, Crohn’s disease and pediatric Crohn’s disease, and ulcerative colitis.

As in other cases, a clinically validated target with commercial success attracts companies to exploit and leverage their new technologies. Next generations of TNF blockers may bring orally bioavailable versions, locally applied TNF blockers, antagonists with higher binding affinities or better tissue penetration due to smaller size. At least 15 clinical stage and 19 preclinical stage are under evaluation in various indications including ophthalmic use, osteoarthritis, Behcet’s disease, organ transplantation, cutaneous sarcoidosis, oral mucositis, atopical dermatitis and sepsis.

The therapeutic drug class of TNF antibodies presently consists of five different approved and marketed products which all together achieved worldwide sales of more than US$ 24 bln in 2011. Among the approved indications for use of TNF antibodies in general are rheumatoid arthritis, idiopathic juvenile arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, psoriasis, ulcerative colitis and Crohn’s disease. However, not all TNF antibodies are the same and their efficacy had to be demonstrated for each indication.

The highly attractive market and the forthcoming expiration of patents has attracted biosuperior as well as biosimilar antibodies. For all of the five marketed TNF antibodies are biosimilar molecules in the R&D pipeline, but with clear priority on the first generation TNF antibody constructs.

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