Biosimilarity Assessment of the Biosimilar Teriparatide Candidate and the Reference Drug in Healthy Subjects.

Wang X, Liang X, Wang T, Zhan Y, Liu H, Li C, Li X, Ma H, Hu Z, Wang X, Xiao S, Ban L, He J, Li Y, Fang Y

Clinical pharmacology in drug development29 Jan 2023Cited by 3 (Europe PMC)

PMID36710466DOI10.1002/cpdd.1221PepBankPUB-36710466

Publisher page PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone6

In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Teriparatide (PTH 1-34).

01HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialPharmacokinetics
In healthy subjects, the SAL001-to-reference teriparatide maximum-concentration ratio met the prespecified biosimilarity confidence-interval criteria.
In plain wordsIn healthy subjects, SAL001 met the biosimilarity criteria for maximum blood concentration compared with reference teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableMaximum plasma concentration biosimilarity
Study
n = 61
Comparator
Reference teriparatide
Outcome group
Pharmacokinetics · Pharmacology
Source sentences
Summary
Overall, the 90%CIs for the geometric mean ratios of C_max , AUC from time 0 to the last quantifiable time point, and AUC from time 0 extrapolated to infinity of the test or reference product were within 80.0%-125.0% of biosimilarity criteria.
3 context sentences(design, population, supporting numbers)
Summary · context
A single-dose, randomized, open-label, 2-way crossover trial was conducted in healthy subjects to compare the pharmacokinetics (PK) and safety between SAL001 and the reference drug.
Summary · context
Sixty-four subjects were enrolled in the study, and 61 subjects completed the study.
Summary · context
In each period, 20 μg of the test or reference formulation was administered subcutaneously.
In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).
Report a problemFND-3671046601
02HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialPharmacokinetics
In healthy subjects, the SAL001-to-reference teriparatide AUC-to-last-quantifiable-time ratio met the prespecified biosimilarity confidence-interval criteria.
In plain wordsIn healthy subjects, SAL001 met exposure biosimilarity criteria through the last measurable time compared with reference teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableAUC to last quantifiable time biosimilarity
Study
n = 61
Comparator
Reference teriparatide
Outcome group
Pharmacokinetics · Pharmacology
Source sentences
Summary
Overall, the 90%CIs for the geometric mean ratios of C_max , AUC from time 0 to the last quantifiable time point, and AUC from time 0 extrapolated to infinity of the test or reference product were within 80.0%-125.0% of biosimilarity criteria.
3 context sentences(design, population, supporting numbers)
Summary · context
A single-dose, randomized, open-label, 2-way crossover trial was conducted in healthy subjects to compare the pharmacokinetics (PK) and safety between SAL001 and the reference drug.
Summary · context
Sixty-four subjects were enrolled in the study, and 61 subjects completed the study.
Summary · context
In each period, 20 μg of the test or reference formulation was administered subcutaneously.
In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).
Report a problemFND-3671046602
03HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialPharmacokinetics
In healthy subjects, the SAL001-to-reference teriparatide AUC-extrapolated-to-infinity ratio met the prespecified biosimilarity confidence-interval criteria.
In plain wordsIn healthy subjects, SAL001 met total exposure biosimilarity criteria compared with reference teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
Not applicableAUC extrapolated to infinity biosimilarity
Study
n = 61
Comparator
Reference teriparatide
Outcome group
Pharmacokinetics · Pharmacology
Source sentences
Summary
Overall, the 90%CIs for the geometric mean ratios of C_max , AUC from time 0 to the last quantifiable time point, and AUC from time 0 extrapolated to infinity of the test or reference product were within 80.0%-125.0% of biosimilarity criteria.
3 context sentences(design, population, supporting numbers)
Summary · context
A single-dose, randomized, open-label, 2-way crossover trial was conducted in healthy subjects to compare the pharmacokinetics (PK) and safety between SAL001 and the reference drug.
Summary · context
Sixty-four subjects were enrolled in the study, and 61 subjects completed the study.
Summary · context
In each period, 20 μg of the test or reference formulation was administered subcutaneously.
In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).
Report a problemFND-3671046603
04HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialPharmacokinetics
In healthy subjects, other pharmacokinetic parameters did not differ significantly between SAL001 and reference teriparatide.
In plain wordsIn healthy subjects, other drug-handling measures did not differ significantly between SAL001 and reference teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeOther pharmacokinetic parameters
Study
n = 61
Comparator
Reference teriparatide
Outcome group
Pharmacokinetics · Pharmacology
Source sentences
Summary
Other PK parameters, serum calcium concentration, and safety profiles had no significant differences between the 2 formulations.
3 context sentences(design, population, supporting numbers)
Summary · context
A single-dose, randomized, open-label, 2-way crossover trial was conducted in healthy subjects to compare the pharmacokinetics (PK) and safety between SAL001 and the reference drug.
Summary · context
Sixty-four subjects were enrolled in the study, and 61 subjects completed the study.
Summary · context
In each period, 20 μg of the test or reference formulation was administered subcutaneously.
In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).
Report a problemFND-3671046604
05HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialSafety outcome
In healthy subjects, serum calcium concentration did not differ significantly between SAL001 and reference teriparatide.
In plain wordsIn healthy subjects, blood calcium did not differ significantly between SAL001 and reference teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeSerum calcium concentration
Study
n = 61
Comparator
Reference teriparatide
Outcome group
Adverse events · Pharmacology
Source sentences
Summary
Other PK parameters, serum calcium concentration, and safety profiles had no significant differences between the 2 formulations.
3 context sentences(design, population, supporting numbers)
Summary · context
A single-dose, randomized, open-label, 2-way crossover trial was conducted in healthy subjects to compare the pharmacokinetics (PK) and safety between SAL001 and the reference drug.
Summary · context
Sixty-four subjects were enrolled in the study, and 61 subjects completed the study.
Summary · context
In each period, 20 μg of the test or reference formulation was administered subcutaneously.
In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).
Report a problemFND-3671046605
06HumanNot a test of Teriparatide (PTH 1-34) aloneRandomized controlled trialSafety outcome
In healthy subjects, safety profiles did not differ significantly between SAL001 and reference teriparatide.
In plain wordsIn healthy subjects, safety profiles did not differ significantly between SAL001 and reference teriparatide.
Peptide
Teriparatide (PTH 1-34)
Outcome
No significant changeSafety profile
Study
n = 61
Comparator
Reference teriparatide
Outcome group
Adverse events · Whole body
Source sentences
Summary
Other PK parameters, serum calcium concentration, and safety profiles had no significant differences between the 2 formulations.
3 context sentences(design, population, supporting numbers)
Summary · context
A single-dose, randomized, open-label, 2-way crossover trial was conducted in healthy subjects to compare the pharmacokinetics (PK) and safety between SAL001 and the reference drug.
Summary · context
Sixty-four subjects were enrolled in the study, and 61 subjects completed the study.
Summary · context
In each period, 20 μg of the test or reference formulation was administered subcutaneously.
In this study, Teriparatide (PTH 1-34) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Teriparatide (PTH 1-34).
Report a problemFND-3671046606

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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