TY  - JOUR
T1  - Next-Generation Biosimilars Need Lifecycle Comparability Rather Than One-Time Similarity Judgments
A1  - Ravi Kumar
A1  - Neha Sharma
A1  - Aniket Deshmukh
A1  - Sanjay Kulkarni
A1  - Arjun Nair
JF  - International Journal of Pharmaceutical Research and Allied Sciences
JO  - Int J Pharm Res Allied Sci
SN  - 2277-3657
Y1  - 2026
VL  - 15
IS  - 3
DO  - 10.51847/21tjzPqfjL
SP  - 123
EP  - 133
N2  - Biosimilarity is established at a defined point in product development, whereas both reference products and biosimilars continue to evolve after approval through manufacturing changes, site transfers, process optimization, formulation updates, and routine lot-to-lot variation. This creates a temporal problem that is poorly described by a one-time similarity judgment. Yet measurable change should not be equated with clinically meaningful drift: contemporary lifecycle evidence includes both documented time-dependent shifts in selected reference-product attributes and examples of long-term biosimilar quality stability. We argue that next-generation biosimilar oversight should therefore treat comparability as a longitudinal evidentiary problem. The proposed approach preserves the original biosimilarity bridge while following independently controlled reference-product and biosimilar trajectories. Analytical surveillance should first determine whether an observed signal is credible, then ask whether it affects mechanism-relevant function, pharmacokinetics, immunogenicity risk, or clinical performance. Clinical reassessment should be triggered by unresolved biologically plausible uncertainty rather than by change alone. This lifecycle framing is intended to improve interpretability and regulatory traceability, not to require routine re-demonstration of biosimilarity.
UR  - https://ijpras.com/article/next-generation-biosimilars-need-lifecycle-comparability-rather-than-one-time-similarity-judgments-mgcpuepusaibw34
ER  -