The FDA’s recent draft provides important nonbinding recommendations on when a comparative efficacy study may not be necessary to support a demonstration of biosimilarity.
Key Takeaways:
- Modern analytical technologies can structurally characterize highly purified therapeutic proteins and model in vivo functional effects with high specificity and sensitivity using in vitro biological and biochemical assays.
- A comparative analytical assessment (CAA) is generally more sensitive than a comparative efficacy study (CES) for detecting differences between products that could affect biosimilarity.
- If the CAA demonstrates that the proposed biosimilar is highly similar to its reference product (allowing for minor differences in clinically inactive components), a human pharmacokinetic similarity study and immunogenicity assessment may be sufficient to evaluate safety, purity, and potency—potentially eliminating the need for a CES.
The FDA suggests sponsors consider a streamlined approach where CES may not be needed, if:
- Both products are manufactured from clonal cell lines, are highly purified, and can be well-characterized analytically,
- Quality attributes and their relationship to clinical efficacy are well understood and measurable by CAA assays,
- A human pharmacokinetic similarity study is feasible and relevant.
As the regulatory landscape shifts, it’s vital for biosimilar sponsors and stakeholders to understand these potential changes to optimize development strategies and ensure compliance.
How could this guidance impact your biosimilar program? Let’s connect to discuss strategy, compliance, and risk mitigation.
For further information and discussion on these points or other matters facing the Life Sciences and Healthcare Industries please contact us.
Yogesh Bahl
Partner
917.347.4386
ybahl@resecon.com