Governing Equations

Tier 1 Equivalence Test (FDA/EMA):
  μ_ref - margin·σ ≤ μ_test ≤ μ_ref + margin·σ
  margin = 1.5 (critical quality attributes)

90% Confidence Interval:
  CI = x̄ ± t(0.05, df) · SE
  SE = s_pooled / sqrt(n/2)

Similarity Index (SI):
  SI = (1 - d / d_max) · 100
  where d = Euclidean distance in quality space

Fingerprint Comparison:
  Fingerprint index = correlation(ref, test)
  FI ≥ 0.90 → highly similar

Immunogenicity Risk Proxy:
  Risk = f(glycosylation, aggregates, sequence identity)
  Risk < 0.3 → acceptable for biosimilar