Ep. 17 Copy That Cure: The Cell and Gene Therapy Biosimilar Challenge

Cell and gene therapies are changing how we treat diseases that were once considered untreatable, but their massive price tags are putting serious pressure on health systems. In this episode of BioDisruptors, we explore whether biosimilars, which are lower cost follow-on versions of biologic drugs, can work for these complex therapies.

Using insights from experts across regulation, manufacturing, intellectual property, and pricing, we dive into the real challenges and opportunities for biosimilar development in cell and gene therapy. From unclear FDA rules and clinical trial delays to secretive manufacturing processes and dense patent strategies, we break down what stands in the way of affordable alternatives

Featured Article:  Introducing Biosimilar Competition for Cell and Gene Therapy Products (https://doi.org/10.1093/jlb/lsae015)