31 Oct 2012, BioSpectrum Bureau , BioSpectrum
Singapore: AET BioTech, the separate biosimilars business within the generic drug developer Alfred E Tiefenbacher (AET) Group and BioXpress Therapeutics, a Swiss-based biotechnology company developing monoclonal antibody (MAb) biosimilars, have entered into an agreement for the co-development of a biosimilar version of the TNF inhibitor monoclonal antibody (MAb) Adalimumab.
Beside active involvement in the development of the MAb, AET BioTech will in particular be responsible for providing further investment in the biosimilar based on committed long term financing. AET BioTech is also responsible for any future commercialization of the product. Adalimumab is currently marketed by Abbott and recorded 2011 global sales exceeding $7.9 billion.
Dr Harm Peters, MD, AET BioTech, said that, "The cooperation with BioXpress on our initial project is a key step in AET BioTech's mission to bring European quality biosimilar drugs to markets worldwide at fair prices."
Dr Cori Gorman, CEO and chair of BioXpress Therapeutics, said that, "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 under strict non-clinical and clinical guidelines as outlined in the European Medicines Agency's 'Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies', the current standard for biosimilar registration incorporated into and referenced by biosimilar legislation in countries worldwide, and will also include non EU requirements into planning at an early stage. It will undergo ethical and comprehensive analytical and clinical comparison to the innovator product to establish its similarity accordingly.