AET BioTech and BioXpress Therapeutics to Co-Develop Biosimilar Adalimumab
AET BioTech, the separate biosimilars business within the generic drug developer AET (Alfred E Tiefenbacher) Group and BioXpress Therapeutics SA, 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 MAb adalimumab.
AET BioTech and BioXpress will be jointly responsible for the development, registration, and manufacture of the biosimilar, which is based on BioXpress technology. The development strategy devised and implemented by the partners incorporates regulatory requirements for marketing in countries worldwide. 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 commercialisation of the product. Adalimumab as currently marketed by Abbott had 2011 global sales exceeding $7.9 billion USD.
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.
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