Since the first monoclonal antibody was approved in 1986, more than 100 different mAbs have been approved by the U.S. FDA and EMA. The use of mAbs has been leading a therapeutic revolution towards more personalized medicine, and their success is underpinned by biotechnology products representing more than 60% of the top-selling products in 2023 versus conventional therapy.
Many factors in mAbs development converged to create a compelling business case for investors to think about biosimilars as a new cost-effective, differentiated therapy for patients. In 2013, EMA approved the first biosimilar version of the mAb infliximab, opening a new market for biosimilars.
After mAbs, cell and gene therapy represents the next frontier of personalized medicine, and the recent success of Chimeric Antigen Receptor T-cell (CAR-T) therapies in certain types of blood tumors is fostering higher demand for patient treatment, and expansion of their development in other therapeutic areas, such as neuroscience and immunology, or solid tumors.
The industry has reached the point where it is now time to evaluate the probability of a future market for biosimilar versions of CAR-T therapies or ‘CAR-T-similars.’
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This article was originally published in American Pharmaceutical Review.
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