Emerging Trends in Biosimilars

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Manufacturing processes for biosimilars stand on their own and need not duplicate the originator’s production methods. Instead, the focus is on extended characterization efforts to show that the biosimilar is ‘highly similar’ to the reference medicine. That can really cut clinical efforts and save developers a lot of money. There are also opportunities for greater process economy through improved production technology as, for example, through the implementation of single-use equipment, more rigorous process monitoring, process intensification, and other improvements.

Emerging trends suggest that Asia is attracting major investors interested in biosimilars industry; the growth prospects are driven by streamlining of regulatory guidelines and high adoption rate for biosimilars among physicians, payers and patients.