Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects (NCT02144714), a randomized phase 1 study. The primary outcome is Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf).

2. Clinical Question

3. Trial Design

The registry identifies this as a Phase 1, randomized, single-blind, three-arm, parallel-group, single-dose study in healthy subjects. Its purpose was to compare the pharmacokinetics, safety, tolerability and immunogenicity of SB5 with EU-sourced and US-sourced Humira®. The sponsor was Samsung Bioepis Co., Ltd., and the study status is listed as completed. The registry reports enrollment of 189.

Each arm received one 40 mg subcutaneous injection: SB5, EU-sourced Humira® or US-sourced Humira®. The parallel-group structure means that participants were assigned to one formulation group rather than crossing between formulations. Randomization is reported; the method used to generate or conceal the allocation is not reported in the registry record. The record describes masking as single-blind but does not specify which study roles were masked.

The primary endpoint was mean AUCinf, measured in μg·h/mL, over the timeframe from 0 to 1680 hours post-dose. The registry describes collection at pre-dose and at the listed post-dose sampling times. The analyzed counts for this endpoint were 53 in the SB5 group, 61 in the EU-sourced Humira® group and 57 in the US-sourced Humira® group. These are endpoint analysis counts, not a description of why any enrolled participant did not contribute to the summary.

The record lists one secondary outcome, Tmax, in hours, and posts results for it. The posted results include group means and standard deviations and pairwise comparisons of each Humira® source with SB5. The registry lists no reported analyses beyond the posted summaries. Further details of the protocol, including the original sample-size rationale and the full statistical analysis plan, are not reported in the registry record.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf), measured over 0 to 1680 hours post-dose.

The primary endpoint is the area under the concentration-time curve from time zero to infinity, abbreviated AUCinf. It is reported as a mean in μg·h/mL, with standard deviation as the measure of spread. AUCinf is a pharmacokinetic measure of overall drug exposure: it aggregates concentration measurements over time rather than describing only one sampling time. The registry specifies a timeframe from 0 to 1680 hours post-dose and lists pre-dose and post-dose sampling times used for the assessment.

Comparing mean AUCinf across formulations addresses whether the observed overall exposure summaries differ between SB5 and each reference formulation. This is relevant to a formulation comparison because exposure over time is a central pharmacokinetic characteristic. The measure is not itself a clinical outcome such as symptom change, and its interpretation is limited to the study population and conditions recorded. This study involved healthy subjects and a single dose; the registry record does not establish how these results translate to other populations, dosing patterns or clinical outcomes.

The reported means are accompanied by standard deviations, which describe variation among the observations around each group mean. The pairwise mean differences and confidence intervals give a direct view of the estimated contrasts and their uncertainty. AUCinf is the designated primary outcome; Tmax is posted as a secondary pharmacokinetic measure and reflects a different feature of the concentration-time profile.

7. Results Posted in the Registry

• EU Sourced Humira®: mean 2,436 versus 2,406 on control; difference 29.90 (95% CI -289.86 to 349.66), standardized effect d = 0.03; z-test p = 0.855.
• US Sourced Humira®: mean 2,423 versus 2,406 on control; difference 17.00 (95% CI -316.42 to 350.42), standardized effect d = 0.02; z-test p = 0.920.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Time to Cmax (Tmax)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • EU Sourced Humira®: mean 149.72 versus 165.96 on control; difference -16.25 (95% CI -47.02 to 14.53), standardized effect d = -0.20; z-test p = 0.301.
  • US Sourced Humira®: mean 166.46 versus 165.96 on control; difference 0.49 (95% CI -31.25 to 32.24), standardized effect d = 0.01; z-test p = 0.976.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between EU Sourced Humira® and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between US Sourced Humira® and the control. The interval gives the range of effects that remain compatible with the data.

The registry posts Tmax as the secondary pharmacokinetic outcome. Unlike AUCinf, which summarizes exposure across the concentration-time profile, Tmax describes the timing of the maximum concentration. It therefore adds a different dimension to the pharmacokinetic description rather than serving as a duplicate measure of overall exposure.

Across the posted secondary comparisons, the broad pattern does not overturn the primary reading: the secondary outcome does not provide a clear basis for a stronger claim about differences among formulations. The primary endpoint remains the main reference point for the study’s stated pharmacokinetic comparison. The secondary measure can be considered alongside it as context about the concentration-time profile, but it cannot resolve the uncertainty in the primary comparison or establish a broader conclusion on its own.

Unadjusted secondary results carry less weight because multiple outcomes and group contrasts create more opportunities for apparently notable findings to occur by chance. The registry record does not report a multiplicity procedure, a hierarchy among secondary outcomes or a confirmatory analysis plan. Without those details, the secondary estimates and p-values are best treated as descriptive and exploratory rather than as independent confirmation.

There is also only one secondary outcome posted, and the registry lists no reported analyses for it beyond the summaries. The absence of a reported multiplicity adjustment does not show that none was considered in the original study; it means the registry record does not document one. Readers should distinguish the existence of a posted secondary estimate from evidence that the endpoint was powered or prespecified to support a formal claim. The endpoint-specific estimates and intervals should be interpreted with their uncertainty, and not selected solely because of a p-value.

Taken together, the secondary measure broadens the description of pharmacokinetics, while the primary AUCinf comparisons remain central. Neither endpoint is a clinical outcome, and neither directly establishes benefit in a patient population.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Time to Cmax (Tmax)

9. Statistical Interpretation

10. Statistical Methods Explained

What does a mean difference represent?

A mean difference expresses the contrast between the average outcome in one group and the average in another, in the outcome’s original units. For AUCinf, the unit is μg·h/mL. The comparison is oriented as Humira® source relative to SB5, so a positive estimate indicates a higher posted mean in the reference group and a negative estimate indicates a lower posted mean. The estimate is a point summary; by itself it does not show how precisely the contrast is known.

The registry reports group means and standard deviations. A mean describes the center of the observed values, while a standard deviation describes their spread around that center. Standard deviations are not confidence intervals for the mean and should not be read as the range containing every participant’s value. In a continuous outcome, individual values can vary substantially even when group means are close.

How should the confidence intervals be read?

A confidence interval gives a range of values compatible with the estimate under the assumptions of the calculation. It conveys uncertainty more directly than a point estimate alone. For these comparisons, the intervals cross zero, meaning that both a lower and a higher mean in the reference group remain compatible with the posted data. A confidence interval that includes zero is not evidence that the groups are exactly alike. It indicates that the data do not pin down the direction and size of a difference with high precision.

The registry’s p-values are unadjusted. A p-value describes how unusual data at least as incompatible with a null comparison would be under the null and the model assumptions; it is not the probability that the null is true, nor a measure of clinical importance. P-values should be considered with the estimated difference and its interval. A large p-value does not establish equivalence, and a small p-value would not by itself establish that a difference matters clinically.

Why do sample sizes and variability matter?

Precision depends in part on how many observations contribute and how variable those observations are. Greater variability makes a group mean harder to estimate precisely for a given amount of information. Smaller group sizes also tend to produce less precise estimates. The posted primary endpoint standard deviations are 825.9 for SB5, 915.7 for EU-sourced Humira® and 957.0 for US-sourced Humira®. The endpoint counts differ by group, and the resulting confidence intervals reflect the information available for each pairwise comparison.

The standardized effect-size summaries and planning illustrations express a mean difference relative to a pooled standard deviation, which can help compare scales. They do not replace the original-unit estimates. A small standardized contrast can coexist with a confidence interval that remains wide in the original units, particularly when group sizes are limited relative to variability. For interpretation, the actual difference, uncertainty interval and outcome scale remain important.

What does an unadjusted re-calculation mean?

The posted pairwise calculations use the group summary statistics for a simple, unadjusted comparison. They are not adjusted for baseline variables or other covariates. The registry record lists no reported analysis results or detailed analysis plan with which to compare these calculations. There is no discrepancy flagged between the posted summaries and these re-calculations. If the sponsor’s own analysis is available, it takes precedence over a calculation reconstructed from summary statistics because the sponsor may have used prespecified methods or participant-level data that are not represented by the summary.

Unadjusted comparisons can be useful for describing the observed group means, but they should not be mistaken for every possible analysis of the trial. For example, the record does not report whether any transformations, covariate adjustments or alternative modeling choices were prespecified or conducted. Those details are not reported in the registry record and cannot be inferred from the rounded summaries.

Why does over-dispersion matter in general?

General statistical context: over-dispersion occurs when variation in the data is greater than a model assumes. If a model understates variability, its standard errors may be too small and its intervals may be too narrow. Models can account for extra variation in different ways, depending on the outcome and design. The posted primary outcome is a continuous measure summarized by means and standard deviations; the registry does not report an over-dispersion model for this analysis. This concept is relevant as a general principle, not a claim about a feature found in this study.

More generally, statistical models rely on assumptions about the form of the outcome distribution, independence and how observations are sampled. The registry summaries do not provide enough detail to assess all model assumptions. Readers can still interpret the posted means, differences, intervals and p-values as descriptive statistical evidence, while recognizing that an interval’s coverage and a test’s calibration depend on the analysis assumptions.

How should the secondary measure fit in?

Tmax is a continuous measure reported as a mean and standard deviation in hours. It describes timing of the maximum concentration, a different characteristic from accumulated exposure. The posted comparisons use the same general mean-difference framework, but the registry does not report a prespecified multiplicity adjustment or a complete set of secondary analyses. Secondary comparisons are therefore less protected against chance findings when multiple outcomes or contrasts are examined. They can add context, but should not be treated as independent confirmatory evidence unless the analysis plan supports that interpretation.

11. Confidence Intervals and Precision

The confidence intervals for the primary AUCinf comparisons are broad relative to their point estimates. For EU-sourced Humira® compared with SB5, the estimated mean difference is 29.9, with an interval from -289.9 to 349.7. For US-sourced Humira® compared with SB5, the estimate is 17.0, with an interval from -316.4 to 350.4. Each interval includes zero and permits differences in either direction. The posted estimates therefore do not determine a precise difference between the group means.

Precision is not the same as whether a result crosses a significance threshold. The interval gives a range of uncertainty, while the p-value compresses the comparison into a test statistic under a null hypothesis and its assumptions. In this study, considering the interval is particularly useful because the point estimates are small compared with the span of values compatible with the data. The evidence is consistent with little difference, but also leaves room for nonzero differences.

The intervals are based on the numbers contributing to each comparison and the observed variability. They describe uncertainty in the mean contrasts, not the spread of individual concentrations or the range of responses expected for a future participant. They also do not account for any unreported multiplicity adjustment or analysis choices. The registry does not report an equivalence margin; without such a margin and a suitable design, an interval that contains zero cannot establish that formulations are equivalent.

Thus, the most defensible precision statement is that the posted primary comparisons have point estimates near zero but remain uncertain over a broad range on the AUCinf scale. A reader should not treat failure to reject a zero difference as proof of no difference.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations expressed as participants per arm for 80% power and participants per arm for 90% power. They are not total enrollment targets and are not total event counts. The planning assumptions listed in the registry-derived material are a two-sided significance level of 0.05, equal allocation between the two arms and a normal approximation. Each illustration uses the stated fraction of the observed effect as the effect to detect. These are not the original design assumptions for the trial; the trial’s own sample-size rationale is not reported in the registry record.

The 80% power column describes a hypothetical design that would have an 80% chance of detecting the specified effect under the planning assumptions, if that effect and model were correct. The 90% column uses a higher target chance of detecting that same specified effect. These percentages are planning targets, not a statement about the chance that the trial result is true or about the probability that the observed analysis found an effect.

Rows for 100% of the observed effect use the full observed point estimate as the planning target; rows for 75% and 50% use smaller target effects. Smaller effects require more participants per arm to detect under the same assumptions, which is why the listed requirements increase as the target fraction decreases. Since the observed contrasts are small, the illustrations can become very large, and they should not be interpreted as a recommended design without a separately justified target effect and protocol.

The curve represents the same relationship between a chosen effect and planning requirements; it is not an additional trial result. These calculations are planning illustrations, not observed power. Observed power is not a useful substitute for interpreting the estimated effects and confidence intervals after a study has been completed.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = 29.900; pooled standard deviation σ = 875.145.
2. n = 2 × (1.96 + 0.842)² × 875.145² / 29.900² = 13,447.9, rounded up to 13,448 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 29.9000000000001                      # observed difference in means
sigma <- 875.144544748793                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2144714)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 13,448 (80% power), 18,003 (90% power)
 75% of observed effect: n per arm = 23,908 (80% power), 32,006 (90% power)
 50% of observed effect: n per arm = 53,792 (80% power), 72,012 (90% power)
power.t.test: 13448.9 
Simulated power at n = 13,448 per arm: 0.800 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when more than one outcome, comparison or analysis is examined. Even when each test uses the same significance threshold, examining several tests increases the possibility of at least one chance finding. This is why a prespecified outcome hierarchy or adjustment procedure can matter, especially when secondary comparisons are interpreted as confirmatory evidence.

The registry posts one primary outcome, AUCinf, and one secondary outcome, Tmax. Each is compared between SB5 and the two Humira® source groups. The record does not report whether a family-wise error procedure, an adjustment for multiple comparisons or a hierarchy among the two reference comparisons was specified. It also does not report an analysis plan describing how the secondary outcome was to be interpreted. These details are not reported in the registry record; their absence from the record is not proof that the original protocol lacked them.

The p-values attached to the posted pairwise comparisons are unadjusted. They should be read as individual comparisons, not as multiplicity-controlled evidence across all outcomes and contrasts. In particular, an unadjusted secondary p-value would carry less confirmatory weight if many outcomes or analyses were examined. The primary comparisons also involve two reference groups, so the distinction between per-comparison inference and an overall family of claims should remain clear.

The registry describes the primary analysis population as participants who contributed to the summary statistics. It does not report the handling of missing concentrations, withdrawals, protocol deviations, exclusions or any sensitivity analyses. Nor does it provide a detailed account of whether analysis populations differed by endpoint. These omissions limit the ability to assess whether the posted summaries reflect all randomized participants or a subset defined by prespecified criteria.

Randomization is reported, but the registry does not provide enough detail to assess allocation concealment, blinding procedures or the analysis plan. These are reporting limitations, not evidence that the procedures were inadequate. A complete assessment would require protocol and analysis documentation that is not reported in the registry record.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: appendicitis (1.6%), psychotic disorder (1.6%).

The registry posts serious adverse-event counts for groups with 63 participants at risk in each arm. The reported counts affected were 1 for SB5, 0 for EU-sourced Humira® and 1 for US-sourced Humira®. The record also identifies appendicitis and psychotic disorder as serious adverse-event terms, each listed as 1.6%. These are descriptive registry summaries, not estimates adjusted for differences in follow-up or participant characteristics.

The deaths fields are not populated; death counts are not reported in the registry record. Serious adverse events are distinct from the broader category of other adverse events, which is also posted separately. The counts do not by themselves establish that a formulation caused an event, and the registry summary does not provide enough detail to evaluate timing, relatedness or individual clinical circumstances.

These results come from a single-dose study in healthy subjects. A study of this size and setting has limited ability to characterize uncommon events or risks under different dosing patterns or in patient populations. The serious-event figures should therefore be read as a record of reported events during this study, not as a comprehensive comparison of long-term safety.

16. What the Result Does, and Does Not, Mean

The posted primary results show similar mean AUCinf values across the three groups, with small estimated pairwise mean differences relative to the uncertainty intervals. Both intervals include zero and extend to differences in either direction. The data therefore do not provide a precise estimate of the direction or size of a difference in mean exposure between SB5 and either Humira® source.

This is not the same as proving that the formulations have identical pharmacokinetics. A non-significant unadjusted comparison cannot establish equivalence, and the registry record does not report an equivalence margin or a non-inferiority framework. A formal equivalence conclusion requires a prespecified acceptable range and analysis designed to assess whether the uncertainty lies within that range. Those conditions cannot be inferred from similar point estimates.

The findings apply to the setting recorded: a single dose in healthy subjects. They do not establish what would occur in people with a condition requiring treatment, with repeated dosing or for clinical outcomes. AUCinf and Tmax are pharmacokinetic measures, not direct measures of symptoms, disease control or quality of life. The registry’s safety summaries also do not establish comparative long-term safety.

The trial can inform understanding of the posted pharmacokinetic profiles for the three formulations under its study conditions. Its conclusions should remain bounded by the analysis population, follow-up and reporting available in the registry. Confidence intervals, not only the point estimates or p-values, show that uncertainty remains. Any broader conclusion would require evidence and design details beyond the registry summaries.

Accordingly, the statistical interpretation is neither that a meaningful difference has been demonstrated nor that all relevant differences have been ruled out. It is that the observed mean contrasts are close to zero, while the reported intervals remain compatible with a range of possible differences. The distinction between lack of clear evidence for a difference and evidence of equivalence is essential.

17. Why This Trial Matters Statistically

This trial is statistically informative because it compares one proposed biosimilar formulation with two reference sources in a randomized, parallel-group design and reports a direct pharmacokinetic endpoint. Separating the EU-sourced and US-sourced reference groups makes each comparison with SB5 visible rather than combining the reference sources into a single group. The study also reports a secondary measure that characterizes a different feature of the concentration-time profile.

The results illustrate why point estimates should be read alongside uncertainty. The AUCinf group means are close, but the confidence intervals are broad enough to include both positive and negative differences. A reader who focuses only on the means or unadjusted p-values could overstate what the study establishes. The intervals make clear that the estimates are not precise enough to demonstrate equivalence without a reported margin and appropriate framework.

The record also provides a useful distinction between pharmacokinetic evidence and clinical evidence. Similar exposure summaries in healthy subjects are not the same as direct evidence about clinical outcomes, and single-dose summaries do not answer questions about repeated use. The study’s design and endpoint make the statistical question specific; interpretation is strongest when it stays within that scope.

Finally, the record shows the importance of transparent reporting. Details about the original sample-size rationale, multiplicity, missing-data handling and full analysis plan are not reported in the registry record. Their absence limits independent evaluation of the intended inferential framework. The posted summaries still support a careful description of estimated exposure differences and uncertainty, but not a broader claim than those summaries can sustain.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

Several limitations are specific to interpreting this registry record. The study involved healthy subjects and a single dose, so its pharmacokinetic summaries do not directly describe repeated dosing or a patient population. The endpoint is a concentration-based measure, not a clinical outcome. The registry’s stated timeframe is from 0 to 1680 hours post-dose, and the results should be understood within that recorded assessment period.

The primary comparison counts contributing to the summary statistics differ across arms. The registry does not explain why the analyzed counts are different or report missing-data methods, exclusions, withdrawals or sensitivity analyses. It is therefore not possible to assess from this record alone whether the analyzed participants were selected according to a particular prespecified rule or how missing observations may have affected the summaries.

The pairwise comparisons are unadjusted, and the registry does not report a multiplicity strategy or detailed analysis plan. It also does not report an equivalence margin, so similar means and intervals crossing zero cannot be treated as an equivalence result. The registry lists no reported analyses beyond the posted summaries, which limits comparison with any sponsor analysis.

The study has limited scope for evaluating uncommon or long-term safety outcomes. Serious adverse-event summaries do not include reported death counts, and the registry does not provide event-level information about timing or relatedness. Further, the masking description does not identify which roles were masked, and details of allocation concealment are not reported. These are limits of what the registry record documents, not evidence that study procedures were absent.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB5 in Healthy Subjects — NCT02144714.
• Registry record last updated 2018-11-14; status last verified 2018-10.
• Results first posted 2018-09-21.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

NCT02144714 is a completed Phase 1, randomized, single-blind, parallel-group study in healthy subjects. It compared single 40 mg subcutaneous doses of SB5, EU-sourced Humira® and US-sourced Humira®, with a registry enrollment of 189. The primary endpoint was mean AUCinf over 0 to 1680 hours post-dose; Tmax was posted as a secondary outcome.

The primary group means were 2406.0 for SB5, 2436.0 for EU-sourced Humira® and 2423.0 for US-sourced Humira®. The unadjusted pairwise intervals include zero and remain broad. The results describe pharmacokinetic summaries in this study setting; they do not establish equivalence or clinical effects. The registry record does not report the original sample-size rationale, multiplicity procedure, missing-data handling or full statistical analysis plan.