Pharmacy Times October 19, 2023
The biosimilar landscape is growing, but the FDA should leverage analytical data to efficiently determine the quality of these products and propel them toward approval, according to a session at the Academy of Managed Care Pharmacy’s Nexus 2023 conference.
While the FDA continues to have high standards of approval for biosimilars, the agency is concentrating efforts on making the development and approval process more efficient, said Juwaria Waheed, MD, a scientific reviewer at the Office of Therapeutic Biologics and Biosimilars with the FDA, during a session at the Academy of Managed Care Pharmacy’s Nexus 2023 Conference.
According to Waheed, having clinical trials for biosimilars is time-consuming and there are numerous limitations. However, focusing more on analytical comparability between a biosimilar...
Today's Sponsors
Today's Sponsor