Immunogenicity and safety of a proposed pegfilgrastim biosimilar MSB11455 versus the reference pegfilgrastim Neulasta® in healthy subjects: A randomized, double‐blind trial
| Autor: | Armin Schueler, Michael Stahl, Christian Schwabe, Radmila Kanceva, Vishal Ghori, Janka Ryding, Chris Wynne, Emmanuelle Vincent, Martin Ullmann |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
safety
medicine.medical_specialty Antidrug antibody RM1-950 immunogenicity 030226 pharmacology & pharmacy Double blind 03 medical and health sciences 0302 clinical medicine Internal medicine medicine antidrug antibodies General Pharmacology Toxicology and Pharmaceutics MSB11455 tolerability business.industry Immunogenicity Healthy subjects Biosimilar pegfilgrastim Confidence interval Neurology Tolerability 030220 oncology & carcinogenesis Therapeutics. Pharmacology business Pegfilgrastim medicine.drug |
| Zdroj: | Pharmacology Research & Perspectives, Vol 8, Iss 2, Pp n/a-n/a (2020) |
| ISSN: | 2052-1707 |
| Popis: | MSB11455 is a proposed biosimilar to the currently licensed reference pegfilgrastim (Neulasta®). This study was designed primarily to compare the immunogenicity of MSB11455 and Neulasta®. As secondary objectives, the safety and tolerability of MSB11455 and Neulasta® were also compared. Healthy adult subjects were randomized to either MSB11455 or Neulasta®, stratified by antipolyethylene glycol (PEG) antibody status at screening and study site. Subjects received a single subcutaneous dose of MSB11455 or Neulasta® (both 6 mg/0.6 mL) on day 1 of each of two study periods (same product in both periods), separated by a washout of 28‐35 days. Immunogenicity samples were taken predose and up to day 84 post–first dose. Noninferiority was confirmed if the upper limit of the exact one‐sided adjusted 95% confidence interval (CI) for the difference in antidrug antibody (ADA)‐positive rates was |
| Databáze: | OpenAIRE |
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