In a pharmacokinetic (PK) and pharmacodynamic (PD) trial in healthy participants, Samsung Bioepis' SB12 eculizumab biosimilar candidate demonstrated equivalence to Soliris, the reference product.
A phase 1 study of the proposed eculizumab biosimilar (SB12) vs reference product (Soliris) has demonstrated pharmacokinetic (PK) bioequivalence and comparable pharmacodynamic (PD), safety, and immunogenicity characteristics in a population of healthy volunteers, investigators reported at the 2021 American Society of Hematology meeting.
Eculizumab is a humanized monoclonal antibody that binds to human C5 complement protein and blocks hemolysis, or the breakdown of red blood cells. Eculizumab is currently indicated for paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome, refractory generalized myasthenia gravis, and neuromyelitis optica spectrum disorder.
Investigators sought to demonstrate comparable PK and PD in healthy individuals aged 18 to 55 years (N = 240) who were randomized in a 3-arm trial to a single 300-mg dose of SB12 or US- and EU-sourced reference product. Blood samples for analysis were collected over 64 days.
The primary end point was PK similarity between the various agents as determined by total drug exposure, or area under the concentration-time curve. Biosimilarity for the primary end point was confirmed, as the 90% CIs were within the predetermined equivalence margin of 80% to 125%, authors of the study wrote.
Investigators said there were no deaths or discontinuation of investigational products (IPs) due to treatment-emergent adverse events (TEAEs); they said there were 2 serious adverse events: renal colic in the SB12 cohort and back pain in the US-eculizumab group. “Both events were considered not related to the IP,” investigators wrote.
They said 70.0%, 65.0%, and 71.3% of patients in the SB12 and EU- and US-sourced eculizumab cohorts, respectively, experienced TEAEs, which investigators said was similar.
The number of participants who developed postdose antidrug antibodies (ADA) to eculizumab was 2 (2.5%), 1 (1.3%), and 0 (0.0%), respectively, authors wrote. “There was no significant difference between treatment groups. None of the [participants] with post-dose ADA to eculizumab had a positive result for neutralizing antibodies.”
Reference
Lee HA, Jang H, Kim Y, et al. A randomized, double-blind, single-dose phase 1 comparative pharmacokinetic study comparing SB12 (eculizumab biosimilar) with reference eculizumab in healthy volunteers. Presented at: ASH 2021; December 11-14, 2021. Abstract 929.
Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings
May 16th 2024Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states as well as cost savings.
What AmerisourceBergen's Report Reveals About Payers, Biosimilar Pricing Trends
May 28th 2023On this episode of Not So Different, Tasmina Hydery and Brian Biehn from AmerisourceBergen discussed results from a recent survey, that were also presented at Asembia 2023, diving into the payer perspective on biosimilars and current pricing trends across the US biosimilar industry.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.
AMCP Posters Tackle Interchangeability and Medicaid, Factors Driving Biosimilar Access
April 24th 2024Two posters from the Academy of Managed Care Pharmacy (AMCP) annual meeting explore how an interchangeable insulin glargine biosimilar plays into Medicaid budgets and the top factors driving access to biosimilars.
AON Saves Over $243 Million With High Biosimilar Adoption
April 22nd 2024Thanks to high biosimilar adoption rates within the community oncology setting, American Oncology Network (AON) saved upwards of $243 million between 2020 and 2023, according to a presentation at the Festival of Biologics USA conference in San Diego, California.