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.
Having the correct primary sequence is absolutely critical for a biosimilar to have similarity and comparability to the innovator drug.
Typically, there are several sequences published for every marketed monoclonal antibody. To ensure BioXpress Therapeutics has identified the correct sequence, the Company has developed a proprietary database of protein sequences 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. Based on the data from the BioXpress database, the biosimilar protein is expressed and compared to the originator to ensure a valid sequence before moving the drug forward.