mAbxience currently has six drugs in development that belong to a new generation of biosimilars, 5 of them known as monoclonal antibodies.
These are biological molecules that are complex both structurally and functionally and that have the ability to recognise and attack a specific antigen, which could be anything from a virus to a specific tumour-cell protein.
Biosimilar drugs, particularly those from monoclonal antibodies, offer a high potential for growth due to a more favourable context characterised by a more reasonable regulatory regime and the expiration of various patents in the coming years.
The pressure on national healthcare services to reduce costs is also a key factor and, according to various studies, biosimilars could contribute savings of $71 billion over a ten-year period in the United States. They could also have a similar effect in the European market.
Safety and effectiveness
Biosimilars are equivalent in terms of quality, efficiency and safety to the reference products. mAbxience ensures this equivalence by putting its drugs through a rigorous comparison testing process. Regulated by the competent authorities, these tests enable us to verify that the biosimilar has a structure and biological activity that is practically identical to the reference product and that there are no significant differences in respect of the risks and benefits between the two drugs.
In addition, mAbxience undertakes extensive clinical trials in order to satisfy all the requisite regulatory requirements of the various regions in which the company is active.
Drug production is carried out using the most up-to-date technology currently on the market, such as disposable bioreactors. Likewise, once the product enters the marketing phase, mAbxience continues clinical follow-up via pharmacovigilance programmes that enable the detection of delayed toxicities, a phenomenon characteristic of all biotechnological drugs, be they biosimilar or not.
The therapeutic applications for monoclonals developed by mAbxience are largely intended to treat the following two areas:
- Oncology: the treatment is used for certain types of cancer, such as breast cancer, colon cancer and some types of lymphoma.
- Autoimmune diseases: such as rheumatoid arthritis.
These two therapeutic areas have a major impact on both society and national healthcare services. As a result, by developing our biosimilars, mAbxience facilitates access to treatments that are often out-of-reach for a large number of patients due to their expense.