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Oct 30, 2012

Firms Ally to Develop Humira Biosimilar

  • AET BioTech and BioXpress Therapeutics are pooling their expertise to develop a biosimilar version of Abbott’s billion-dollar TNF-α-blocking antibody adalimumab (Humira®). AET BioTech is the biosimilars operation of generic drugs firm AET. BioXpress is a Swiss biotech focused on the development of monoclonal antibody (mAb) biosimilars. The firms aim to jointly develop, register, and manufacture the biosimilar, based on BioXpress technology. AET will shoulder commercializing the resulting antibody, and will in addition provide further investment in terms of committed long-term financing.

    “The AET BioTech BioXpress agreement is an important step in moving one of our biosimilar projects to the market,” comments Cori Gorman, Ph.D., BioXpress CEO. “AET BioTech’s commercial contacts, biosimilar development, and registration experience and committed financial investment, and our mAb development expertise will help establish our companies as leaders in the biosimilar space.”

    As Abbott’s top-selling drug, Humira made sales of $2.3 billion in the third quarter of 2012, up 15.7% on Q3 2011. Sales for the first nine months of 2012 were $6.6 billion, up 19.3%. The drug is approved in various global markets, for the treatment of rheumatoid arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and moderate-to-severe polyarticular juvenile idiopathic arthritis.

    Earlier this month the EC’s Committee for Medicinal Products for Human Use (CHMP) recommended approving Humira for the treatment of pediatric patients (aged 6 to 17 years ) with severely active Crohn's disease who failed, are intolerant to, or have contraindications to conventional therapy. Just last month FDA approved Humira for inducing and sustaining clinical remission in adults with moderately-to-severely active ulcerative colitis, following failure of other treatments. And in July and August the EC cleared the drug for treating adults with severe nonradiographic axial spondyloarthritis, and for the treatment of adult patients with moderately active Crohn’s disease. The drug had previously been approved for patients with severely active disease. 


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