Regulatory challenges in biosimilar approval

[Vinayak]

Regulatory approval of biosimilars presents unique challenges due to their complex structure and production from living cells. Unlike generics, biosimilars require extensive analytical, non-clinical, and clinical studies to prove similarity to the reference biologic. Regulatory frameworks differ globally—while the FDA and EMA have clear pathways, developing countries face inconsistencies. Ensuring safety, efficacy, and immunogenicity without exact duplication adds complexity. Regulatory affairs professionals play a key role in navigating these hurdles to bring affordable biologic alternatives to market.