TY  - JOUR
T1  - Interpreting Biosimilar Switching Across Single, Multiple, Biosimilar-to-Biosimilar, and Reverse Treatment Sequences
A1  - Carlos Ramirez
A1  - Elena Torres
A1  - Pablo Ortega
A1  - Sofia Mendes
JF  - International Journal of Pharmaceutical Research and Allied Sciences
JO  - Int J Pharm Res Allied Sci
SN  - 2277-3657
Y1  - 2026
VL  - 15
IS  - 4
DO  - 10.51847/LYEuGd9rKe
SP  - 1
EP  - 12
N2  - Biosimilar switching is often discussed as a single intervention, although reference-to-biosimilar, repeated reference–biosimilar alternation, biosimilar-to-biosimilar switching, and return to a previous product represent different exposure histories. Combining these sequences can make reassuring evidence appear more transferable than the underlying studies permit. To critically synthesize recent clinical and review-level evidence on biosimilar switching and identify which conclusions are directly supported, context dependent, or still unresolved across products, diseases, outcomes, and switching sequences. A structured critical-review approach was used. Review-level syntheses formed the interpretive foundation, and recent randomized, prospective, registry, and real-world studies were examined where they added direct evidence for sequences or outcomes insufficiently represented in earlier reviews. Evidence was organized by product, switching direction and frequency, therapeutic context, outcome domain, follow-up, and study design. The approach was deliberately interpretive rather than exhaustive or meta-analytic. The evidence is most mature for selected anti-tumour necrosis factor agents and for single reference-to-biosimilar transitions. Randomized and prospective studies now provide direct support for several repeated-switch and biosimilar-to-biosimilar sequences, particularly involving adalimumab and infliximab, without consistent deterioration in pharmacokinetics, efficacy, safety, or measured immunogenicity within the evaluated conditions. Confidence is lower for uncommon outcomes, long-latency harms, reverse switching, some biologic classes, and transfer across products or care settings. Persistence and subjective post-switch symptoms are clinically important but cannot be treated as direct measures of molecular comparability. Biosimilar switching evidence is broadly reassuring but not sequence neutral. The most defensible conclusion is conditional: a studied product and exposure sequence may be supported for the outcomes and observation period evaluated, while broader class-wide or sequence-wide claims require explicit qualification.
UR  - https://ijpras.com/article/interpreting-biosimilar-switching-across-single-multiple-biosimilar-to-biosimilar-and-reverse-tre-axjvjakqu1ahvr3
ER  -