Webinar: Experts Discuss Avenues to Improve Biosimilar Development Efficiency
A webinar hosted by Biopharma Excellence featured an in-depth discussion on the ways that updated guidelines, a reduction in clinical efficacy testing, and biomarker analyses can have on the efficiency of biosimilar development.
Many experts have called for a reduction in clinical efficacy testing for biosimilars because they may not provide additional safety or efficacy information outside of pharmacokinetic and pharmacodynamic studies are already required. Greater education on the comparable safety of biosimilars compared with their originators could help quell remaining concerns.
Biopharma Excellence is a Germany-based organization that partners with biopharmaceuticals companies to help them develop solutions to the typical scientific, regulatory, and commercialization challenges unique to manufacturing biologic drugs. The live webinar was part of the Science Huddle, a series of quarterly panel discussions, and was titled “20 years of Biosimilars: Are We on the Right Track?”
The presenters emphasized that although biosimilars have the potential to increase access to biologic therapies and reduce health care costs, there are still barriers to their development and adoption, including a long and expensive development process, where manufacturers must conduct a series of preclinical and clinical analyses to obtain regulatory approval. Read the full article on The Center for Biosimilars.