Biography
Biography: Vivek Halan
Abstract
Biosimilars are increasingly being developed by many companies and used as therapeutics for various diseases worldwide. There is a lot of scope to improve in biosimilar story. Biosimilar products are approved through stringent regulatory pathways in highly regulated markets such as the US, EU, Japan, Canada and Australia following loss of exclusivity of their originator reference product. The development of biosimilar product possesses various challenges such as comparable quality, safety and efficacy to a reference product in addition to other challenges in product development from laboratory to manufacturing scale. Biosimilar from process development, pre-clinical trials and clinical trials upto fill finish meets number of challenges. Quality attributes of monoclonal antibody or bio-therapeutic proteins are highly affected by both process and product related impurities. There should be an efficient upstream as well as downstream process to overcome all the bottlenecks and establishing appropriate standards for biosimilarity remains an important area for scientific, legislative and regulatory debate. I would like to give an overview on biosimilar development in various countries and current scenario. My discussion is intended for audience from biopharma industry as well as from active collaborators from various institutes and universities.