The healthcare ecosystem is driven by several factors. Government vision, successful partnerships, modern legislation, and adoption of innovation are some of the most crucial ones from a regulation point of view. Regulatory affairs (RA) bridge the gap between regulatory authorities and market access for drugs allowing patient empowerment by increasing drug availability. With ever-changing laws, RA is constantly subjected to obstacles. Thus, it is crucial to stay updated with the latest guidelines, legislations, and technological disruptors.
The 7th GCC Regulatory Affairs Pharma Summit 2022, held on the 21st and 22nd March in Dubai, provided the platform for international and local industry experts and professionals to engage with each other and exchange insight regarding drug approval processes and regulations to enhance healthcare access for patients. Additionally, sessions on mergers and acquisition, eLabeling, business development and artificial intelligence in track and trace were delivered that provided a holistic overview of the advances in the industry for the GCC region. Drug-related concerns in post approval lifecycle management, value-based pricing and biosimilars & interchangeability were also addressed followed by interactive question and answer sessions that allowed industry experts to extract more information on these important issues.As Silver Sponsors of the 7th GCC Regulatory Affairs Pharma Summit 2022, Co-Director Dr. Neeraj Pant delivered a thorough and detailed session on Biosimilars and Interchangeability that was well received at the Summit. The objective was to emphasize the importance of biosimilar in therapeutics today, how the availability of biosimilar can remove the cost burden that the healthcare ecosystem experiences, and how critical it is for regulatory agencies of the emerging economies to define regulations pertaining to biosimilar registration as well as interchangeability. It will be more beneficial for agencies to list interchangeable biosimilars in order to facilitate substitution at pharmacy level, compared to physicians being solely responsible for biosimilar interchangeability.