Pharmacokinetic and Pharmacodynamic Bioequivalence of Pegfilgrastim-cbqv Delivered via a Prefilled Autoinjector and Prefilled Syringe in Healthy Male Participants

IntroductionPegfilgrastim-cbqv (UDENYCA & REG;; Coherus BioSciences, Redwood City, CA, USA) is a pegfilgrastim (Neulasta & REG;; Amgen, Thousand Oaks, CA, USA) biosimilar approved for administration by prefilled syringe (PFS). The recently approved pegfilgrastim-cbqv prefilled autoinjector (AI) was developed as another method of self-administration and to aid in-office use, providing flexibility in drug delivery. The objectives of the study were to assess the pharmacokinetics (PK) and pharmacodynamics (PD) to determine bioequivalence of the prefilled AI and the PFS for administration of pegfilgrastim-cbqv and to assess the safety profile of the prefilled AI.MethodsDuring this open-label, two-period crossover study, healthy adult males (N = 155) were randomly assigned (1:1 ratio) to receive a subcutaneous injection of pegfilgrastim-cbqv using a prefilled AI (n = 76) or a PFS (n = 79) in period 1. During period 2, participants received an injection using the other method. Primary PK and secondary PD parameters were calculated to assess the bioequivalence of the treatment as administered by the two delivery methods. Safety and immunogenicity were also assessed.ResultsThe 90% CIs of the geometric mean ratios for the PK and PD parameters were within the required range (80-125%), demonstrating bioequivalence between the pegfilgrastim-cbqv prefilled AI and PFS. Treatment-emergent adverse events (TEAEs) were reported by 75% and 74.1% of participants in the prefilled AI and PFS groups, respectively. The most common TEAEs in both treatment groups were myalgia, bone pain, and headache. AI-device-related TEAEs were injection site pain (1.4%) and injection site bruising (0.7%). The incidence of antidrug antibodies and neutralizing antibodies was low and was similar in both treatment sequences.ConclusionsThe bioequivalence of pegfilgrastim-cbqv administered using a prefilled AI and a PFS was established. The safety, including immunogenicity profiles, of pegfilgrastim-cbqv administered using the prefilled AI and the PFS were similar, with no new safety findings. Pegfilgrastim-cbqv is used 24-96 h after chemotherapy to prevent febrile neutropenia. This is when a patient has a fever and a lower-than-normal number of white blood cells. Pegfilgrastim-cbqv is also used to treat someone who has a fever and a low number of white blood cells after high radiation exposure (hematopoietic acute radiation syndrome). Pegfilgrastim-cbqv is given as an injection by hand. The syringe is already filled with the drug. The US Food and Drug Administration also approved a prefilled autoinjector as another way to give the drug. The autoinjector is a spring-loaded system that delivers pegfilgrastim-cbqv in less than 10 s. A shield covers the needle before and after the drug is given. The autoinjector is safe and effective for patients to give pegfilgrastim-cbqv to themselves and for health care staff to use in-office. This study looked at whether the way in which pegfilgrastim-cbqv moves through the body (pharmacokinetics) and its effects on the body (pharmacodynamics) were similar in healthy adult males when using a prefilled autoinjector and a prefilled syringe. Side effects were also assessed. The two administration methods had very similar pharmacokinetic and pharmacodynamic results for pegfilgrastim-cbqv. The side effects for both groups were also similar. The most common side effects were muscle aches and pains, bone pain, and headaches. Giving pegfilgrastim-cbqv with the prefilled autoinjector was very similar to giving it with the prefilled syringe and the pharmacokinetics, pharmacodynamics, and safety were similar.