The FDA has released updated guidance on biosimilar development, emphasizing comparative analytics and quality considerations. This guidance provides a clear roadmap for faster, science-driven approvals and helps ensure safe, effective, and high-quality therapies reach patients sooner.
Key Points:
● Analytics first:
Robust comparative studies form the foundation of biosimilar development.
● More lots, more confidence:
FDA recommends at least 10 reference product lots and 6–10 proposed biosimilar lots.
● Risk-based focus:
Prioritize quality attributes that impact safety, efficacy, and immunogenicity.
● Modern methods:
Orthogonal assays, functional testing, and stability studies strengthen the development package.
●Smarter clinical studies:
Strong analytics may reduce the need for extensive clinical trials.