Unifying Standards: The Need for Streamlined Biosimilar Development
Tue, 22
Oct
2024
Posted by: Biocon Biologics
Cory Wohlbach, global vice president, biosimilars regulatory affairs at Teva Pharmaceuticals, provided an overview of biosimilar streamlining, focusing on progress made over the past couple years. He highlighted key advancements, such as the removal of animal toxicology testing and improvements in interchangeability status.2
Wohlbach emphasized the importance of global harmonization, noting the role of international regulatory experts. He also discussed recent updates, including the FDA's plan for an updated interchangeable guidance and a draft guidance for labeling.3 Looking ahead, Wohlbach outlined potential streamlining steps, including reducing routine requirements for clinical efficacy studies and moving towards a global comparator.
Elena Wolf-Holz, MD, PhD, head of the clinical development department at Biocon Biologics, discussed the regulatory landscape and the criteria for waivers of comparative efficacy studies (CES). She referenced a publication that outlined when a CES may be necessary and highlighted the status quo in the regulatory landscape, noting that clinical trials are not mandated for some markets. Wolf-Holz explained ongoing work at the FDA and European Medicines Agency (EMA) aimed at streamlining the process and creating a clear path for industry investments. She presented EMA and FDA papers, concluding that comparative efficacy studies were not predictive for marketing authorization.
Author:
Biocon Biologics
Biocon Biologics