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Anabion pembrolizumab biosimilarHumanised IgG4 anti-PD-1 monoclonal antibodyANABION
Biosimilar to reference pembrolizumab

Anabion pembrolizumab biosimilar

A humanised IgG4 anti-PD-1 monoclonal antibody developed as a biosimilar to reference pembrolizumab.

Similarity rests on a totality of evidence: analytical and functional comparability, a phase 1 pharmacokinetic study, a phase 3 equivalence study in 480 patients with advanced melanoma, and real-world evidence across tumour types.

480
Patients in the phase 3 equivalence study in advanced melanoma
131
Patients in the phase 1 pharmacokinetic equivalence study
4
Real-world studies across multiple tumour types
The biosimilar evidence paradigm

Clinical data confirm what analytical data establish

For a biosimilar, the weight of proof sits in physicochemical and functional characterisation. Clinical studies confirm similarity rather than establish it. Demonstrated similarity is the scientific basis for extrapolation to the other authorised indications of the reference product.

1
Analytical and functional comparability
Structure, post-translational modifications, purity and biological function compared across more than 14 biosimilar and 15 reference batches.
2
Phase 1 pharmacokinetics
Equivalent exposure after the first infusion in 131 patients, near-identical PD-1 receptor occupancy, no anti-drug antibodies.
3
Phase 3 clinical equivalence
Double-blind randomised study in 480 patients with advanced melanoma. Primary equivalence endpoint met; survival, immunogenicity and safety comparable.
4
Real-world evidence
Prospective and retrospective studies in routine practice, including a 382-patient non-medical switch cohort.
Totality of evidence

Similarity demonstrated at every level of the development programme

The comparability exercise followed WHO TRS 1043 Annex 3 and EMA/CHMP/BMWP/403543/2010. Each step builds on the one before it.

Foundation01

Analytical and functional comparability

More than 14 biosimilar and 15 reference batches compared: structure, post-translational modifications, purity and biological function all within reference ranges.

Phase 102

Pharmacokinetic equivalence and pharmacodynamics

131 patients. AUC0–504 and Cmax 90% CIs within 80–125%; PD-1 receptor occupancy difference <1%; no anti-drug antibodies.

Phase 303

Clinical equivalence in advanced melanoma

480 patients with advanced melanoma. ORR 33.3% vs 32.7%; difference 0.7% (95% CI −7.7; 9.1), within ±15% margins.

Routine practice04

Real-world evidence

Prospective and retrospective studies in routine practice, including a 382-patient non-medical switch cohort.

Why extrapolation is scientifically justified
Pembrolizumab acts through a single mechanism, PD-1 receptor blockade, in every approved indication. When a biosimilar is highly similar in structure, function, pharmacokinetics and clinical performance in a sensitive population, the same efficacy and safety can be expected in the other indications of the reference product. This principle is embedded in WHO and EMA biosimilar guidelines.

Analytical and phase 1 data: ANABION data on file. Comparability exercise per WHO TRS 1043 Annex 3 and EMA/CHMP/BMWP/403543/2010.