Prometheus Laboratories Partners with Celltrion to Validate Therapeutic Drug Monitoring for Subcutaneous Infliximab
Key Insights
Prometheus Laboratories (search) announced a collaboration with Celltrion USA (search) to validate and expand Anser IFX therapeutic drug monitoring testing for patients receiving ZYMFENTRA (search), the only FDA-approved subcutaneous infliximab formulation.
The partnership enables validation of therapeutic drug monitoring for both intravenous and subcutaneous infliximab, supporting the growing demand for at-home treatment options in inflammatory bowel disease (search).
Anser IFX testing uses a drug-tolerant homogeneous mobility shift assay to provide clinicians with objective data on drug concentrations and anti-drug antibodies for optimizing treatment strategies.
Prometheus Laboratories (search) Inc., a leader in precision healthcare, announced a collaboration with Celltrion USA (search), Inc. to validate and expand the upper limit of quantitation for Anser® IFX (infliximab) therapeutic drug monitoring (TDM) testing for patients receiving ZYMFENTRA (search)® (infliximab-dyyb). ZYMFENTRA represents the only FDA-approved subcutaneous infliximab formulation for maintenance treatment in adults with moderately to severely active Crohn's disease (search) and ulcerative colitis (search) following intravenous infliximab.
Advancing Therapeutic Drug Monitoring Technology
The collaboration centers on extending validation of Prometheus's proprietary homogeneous mobility shift assay (HMSA) platform to subcutaneous infliximab dosing. Anser IFX testing uses this drug-tolerant HMSA to provide clinicians treating immune-mediated diseases with objective data on drug concentrations and the presence of anti-drug antibodies. This data guides informed therapeutic decisions to support adequate drug exposure and persistent response, making it a valuable tool for optimizing treatment strategies.
"As pioneers in therapeutic drug monitoring, we're pleased to extend the validation of our proprietary HMSA platform to subcutaneous infliximab dosing," shared Patricia Vasquez, President at Prometheus. "This collaboration with Celltrion USA (search) supports gastroenterologists in their efforts to better understand the exposure-response relationship to give patients an improved chance of sustaining disease control and response on this convenient form of at-home treatment for these debilitating diseases."
First Laboratory to Validate Both Formulations
Prometheus becomes the first specialty laboratory to validate TDM testing for both intravenous and subcutaneous infliximab, supporting the growing demand for at-home treatment options. When dosing is optimized, biologics such as infliximab are highly effective for managing Crohn's disease (search) and ulcerative colitis (search).
The Anser testing platform has demonstrated significant clinical utility since its launch in 2012, with nearly 480,000 Anser tests performed for more than 220,000 unique patients. The proprietary family of homogenous mobility shift assays is used to optimize biologic and biosimilar therapy in autoimmune diseases, simultaneously measuring biologic drug and anti-drug antibody levels in serum. Tests are available for therapeutic drug monitoring of adalimumab, infliximab, ustekinumab, vedolizumab and risankizumab, with the platform cited in over 100 peer-reviewed publications or abstracts.
Supporting Patient-Centered Care
"At Celltrion, having developed the world's first biosimilar monoclonal antibody, we remain committed to advancing IBD care through a patient-centered approach, cutting-edge research and continuous innovation," stated Thomas Nusbickel, Chief Commercial Officer at Celltrion USA (search). "IBD patients value the convenience of self-administering their maintenance treatments at home with ZYMFENTRA (search). This collaboration with Prometheus will support their providers in ensuring optimal drug concentrations and disease monitoring."
Clinical Considerations for ZYMFENTRA
ZYMFENTRA (search) carries important safety considerations, including a boxed warning for serious infections and malignancy. Patients treated with TNF (search) blockers, including ZYMFENTRA, face increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Common adverse reactions occurring in 3% or more of patients include COVID-19, anemia, arthralgia, injection site reactions, increased alanine aminotransferase, and abdominal pain in ulcerative colitis (search) patients. For Crohn's disease (search) patients, additional common reactions include headache, upper respiratory tract infection, diarrhea, increased blood creatine phosphokinase, hypertension, urinary tract infection, neutropenia, dizziness, and leukopenia.