The MAb-based drug market is one of the fastest growing categories of the biopharmaceuticals industry. These products are of high value for pharmaceutical industry, both in research as well as drug development activities.
Biosimilar biologics are complex protein structures. The highly experienced BioXpress Therapeutics team has worked on the development of 12 originator MAbs currently on the market. Since Q2 2010, BioXpress Therapeutics has completed the validation of protein sequence, cell line development, analysis of production cell line, and pre-Phase I clinical plans for its first four biosimilar MAbs: adalimumab, bevacizumab, rituximab and trastuzumab.
Each BioXpress Therapeutics monoclonal antibody (MAb) biosimilar drug is 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.” Furthermore, each BioXpress Therapeutics biosimilar goes through a complete analytical comparison to determine the product is similar to the innovator product.
To ensure BioXpress Therapeutics has identified the best opportunity within the MAb biosimilar arena, the Company has developed a proprietary database of twenty-five data points for each drug, based on comprehensive analysis of literature and patent databases. All data entry and data analysis is done by the Company’s team, which consists of scientists who have been actively involved in making monoclonal antibody therapeutics since the early 1980s. As a result, the BioXpress scientific team is well versed in the literature and groups who have developed many of the originator MAbs over the decades.
website: www.bioxpress.com