AET BioTech and BioXpress Therapeutics have entered into an agreement to codevelop a biosimilar version of Abbott’s tumor necrosis factor inhibitor monoclonal antibody (mAb) adalimumab, currently marketed under the trade name Humira. Both companies will be actively involved in the development, registration, and manufacture of the biosimilar, which will utilize BioXpress Therapeutics’ technology.
AET BioTech’s managing director Harm Peters believes that "the cooperation with BioXpress on the initial project is a key step in AET BioTech's mission to bring European quality biosimilar drugs to markets worldwide at fair prices." In a press statement, Peters, said, "The BioXpress team has an impressive track record in the development of the initial originator mAbs, and access to the state of the art of mAb know-how and technology, and the partnership will unite our technical and commercial strengths behind the adalimumab biosimilar."
Under the terms of the agreement, AET BioTech will provide further investment for the long-term financing of this project and be responsible for any future commercialization of the biosimilar. The development strategy agreed on between the two partners also includes regulatory requirements for worldwide marketing of the biosimilar.
"The AET BioTech BioXpress agreement is an important step in moving one of our biosimilar projects to the market. AET is well known for quality drug development, executing complex development and registration strategies and successful commercialization worldwide, and this is particularly important when developing biosimilars," Cori Gorman, CEO and chair of BioXpress Therapeutics said in a press statement. "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."
The adalimumab biosimilar will be developed following the standard guidelines outlined in the European Medicines Agency’s "Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies," which is recognized by biosimilar legislation in countries worldwide. Non-EU requirements will also be taken to account during the early stage planning. Comprehensive analytical testing and clinical comparison studies will be conducted to establish the similarity between the biosimilar and the innovator biopharmaceutical product.
Global sales of adalimumab exceeded $7.9 billion in 2011. The product is marketed for the treatment of inflammatory diseases such rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, and ulcerative colitis.