The advent of biosimilar adalimumab in the European Union was among the most eagerly awaited events for biosimilar stakeholders in 2018. During this week’s European Crohn’s and Colitis Organisation’s 14th Congress, held in Copenhagen, Denmark, research teams are presenting findings concerning antidrug antibody (ADA) development related to adalimumab and therapeutic drug monitoring (TDM) of one of those adalimumab biosimilars: Amgen’s ABP 501, sold in the European Union as Amgevita.
The advent of biosimilar adalimumab in the European Union was among the most eagerly awaited events for biosimilar stakeholders in 2018. During this week’s European Crohn’s and Colitis Organisation’s 14th Congress, held in Copenhagen, Denmark, research teams are presenting findings concerning one of those adalimumab biosimilars: Amgen’s ABP 501, sold in the European Union as Amgevita.
First, researchers from Amgen and from the Medical University of Vienna in Vienna, Austria, will present a post hoc analysis that seeks to identify factors that influence the development of binding anti-drug antibodies (ADAs) to adalimumab.1
The researchers analyzed data from the randomized, double-blind, 26-week, active-controlled study that was used to support a demonstration of clinical equivalence between the biosimilar and the reference adalimumab in adalimumab-naïve patients with rheumatoid arthritis (RA).
Validated assays were used to detect the presence of binding ADAs, and the investigators used a logistic regression to the week 26 ADA status in patients who were ADA-negative at week 12.
Of 526 patients tested, 353 patients tested negative for binding ADAs thorough week 12, and 52 patients developed binding ADAs at week 26.
They found that baseline factors, including body mass index, albumin, glucose, platelet count, and C-reactive protein did not correlate with development of binding ADAs; however, log-transformation of pharmacokinetic (PK) trough at week 12 was strongly correlated with the development of binding ADAs at week 26.
“Earlier monitoring of PK levels may provide insight into ADA formation in patients treated with adalimumab,” they concluded.
Second, researchers from Spain will report on a therapeutic drug monitoring (TDM) test that has been validated for use with the biosimilar agent.2
The Promonitor-ADL test is frequently used to monitor patients with inflammatory bowel disease who are treated with adalimumab, and the research team will report that they validated this test for the quantification of the biosimilar in comparison with its reference.
The researchers used requirements set forth under the Clinical and Laboratory Standards Institute’s guideline for the lower limit of quantification (LLOQ) and for imprecision and bias. LLOQ was determined with 4 human serum sample matrices per each of 3 low-level adalimumab concentrations, replicated 3 times per 2 lots of the testing kit for the reference and biosimilar over 3 days. Imprecision was evaluated using 3 replicates of 5 sample matrices that represented clinically relevant adalimumab concentrations.
The investigators found that the test can equally measure adalimumab either in the reference biologic or in the biosimilar product; the test was able to quantify ABP 501 in the measurement range of 0.9 to 10.9 mcg/mL with a bias estimate of −0.089 to 0.306 mcg/mL, and with an overall imprecision of 6% to 9%.
The test “can equivalently measure either the reference ADL or the approved biosimilar AMGEVITA with the same sensitivity, precision and accuracy,” write the authors.
References
1. Reinisch W, Rauter I, Chen L, Gessner M, Fanjiang G. Factors that may influence the development of anti-drug antibodies to adalimumab. Presented at: 14th Congress of the European Crohn’s and Colitis Organisation; March 6-9, 2019; Copenhagen, Denmark. Abstract P624. ecco-ibd.eu/publications/congress-abstract-s/item/p624-factors-that-may-influence-the-development-of-anti-drug-antibodies-to-adalimumab.html/.
2. Ruiz-Argüello MB, Maguregui A, Martínez A, Nagore D. Adalimumab therapeutic drug monitoring test validated for measuring ABP 501 biosimilar. Presented at: 14th Congress of the European Crohn’s and Colitis Organisation; March 6-9, 2019; Copenhagen, Denmark. Abstract P329. ecco-ibd.eu/publications/congress-abstract-s/item/p329-adalimumab-therapeutic-drug-monitoring-test-validated-for-measuring-abp-501-biosimilar.html.
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.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Patients With IBD Experience Nocebo Effect Post Mandatory Switch to Biosimilar
May 11th 2024In Canada, a study on patients with inflammatory bowel disease (IBD) switching to infliximab or adalimumab biosimilars found no change in clinical remission or antidrug antibodies after 24 weeks, but 13% experienced the nocebo effect, leading to one-fifth discontinuing therapy.
Biosimilars Gastroenterology Roundup for January 2024—Podcast Edition
February 4th 2024On this episode of Not So Different, we reminisce on all the major gastroenterology news from January, which brought several reports quantifying how the gastroenterology biosimilar market is progressing and marked the 1-year anniversary of adalimumab biosimilar competition in the US.
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.