No Established Connection Between Switching to Adalimumab-ADBM and Diffuse Large B-Cell Lymphoma
Switching from weekly Humira to the biosimilar adalimumab-ADBM does not increase the risk of diffuse large B-cell lymphoma (DLBCL) based on current evidence. The lymphoma risk is inherent to the TNF-inhibitor drug class itself, not to the specific formulation or switching between products.
Understanding the Lymphoma Risk with TNF Inhibitors
All TNF inhibitors, including both reference adalimumab (Humira) and its biosimilars, carry a baseline risk of lymphoma that is related to the mechanism of TNF-alpha blockade, not to differences between products 1.
The risk of malignancy, including lymphoma, is a known class effect of TNF antagonists and applies equally to reference products and biosimilars 1.
This risk exists regardless of whether a patient remains on the reference product or switches to a biosimilar 1.
Evidence on Biosimilar Switching Safety
Switching Does Not Alter Safety Profiles
Multiple guideline documents confirm that switching from reference adalimumab to biosimilars shows comparable safety profiles with no new safety signals 1.
Studies evaluating switches from reference adalimumab to various biosimilars (including SB5, GP2017, MSB11022, and others) demonstrated similar adverse event rates, with no increased risk of serious adverse events or malignancies 1, 2.
A comprehensive review of 22 studies involving at least 10 biosimilars across multiple therapeutic switches showed that immunogenicity and safety did not change quantitatively or qualitatively as a result of switching 1.
Real-World Evidence
Real-world data from Europe, where adalimumab biosimilars have been available since 2017, show no reports of harm specifically associated with adalimumab biosimilar switching 1.
A prospective study of biosimilar-to-biosimilar switching in Crohn's disease (including multiple switches) found no safety signals beyond those already known for the drug class, with only 11.5% experiencing side effects comparable to pre-switch rates 3.
Multiple switching studies (up to three switches between reference and biosimilar) demonstrated no meaningful differences in serious adverse events or safety concerns 4.
Pharmacovigilance Considerations
Monitoring Requirements
Robust pharmacovigilance systems are in place for all biologics, including biosimilars, to detect rare safety events 1.
The Belgian regulatory agency (FAGG/AFMPS) requires a risk management plan for each biosimilar with permanent safety follow-up after authorization 1.
When switching between products, accurate recording of the specific biologic product is essential for adverse event reporting 1.
What to Monitor
- Continue standard monitoring for TNF-inhibitor therapy, including:
Clinical Bottom Line
The risk of DLBCL is related to TNF-inhibitor exposure itself, not to switching between adalimumab formulations 1.
Biosimilar adalimumab-ADBM has demonstrated bioequivalence and comparable safety to reference adalimumab 1.
No evidence suggests that switching from weekly Humira to adalimumab-ADBM increases lymphoma risk beyond the baseline class effect 1.
If a patient develops lymphoma while on any TNF inhibitor (reference or biosimilar), this represents a known risk of the drug class rather than a consequence of switching 1.
Common Pitfalls to Avoid
Do not attribute lymphoma development to the switching process itself—the temporal association does not imply causation when the risk is inherent to the drug class 1.
Avoid unnecessary anxiety about biosimilar switches—the stringent regulatory approval process ensures biosimilarity in efficacy, safety, and immunogenicity 1.
Do not perform different monitoring for biosimilars versus reference products—the same pharmacovigilance approach applies to both 1.