AlpinaBioTech Digest - June 2026

This month's ten articles concentrate on a shift that is already affecting bioanalytical workflows: the redistribution of regulatory evidentiary weight onto PK and anti-drug antibody assays in biosimilar development. EMA's March 2026 reflection paper removes the comparative efficacy study requirement for well-characterised biologics, a change illustrated in practice by the CHMP's June 2026 positive opinion for Denosumab Ascend. A companion piece examines how a May 2026 scoping review in JAMA Health Forum and the FDA's March 2026 Revision 4 draft guidance together expose persistent inconsistencies in immunogenicity requirements across 19 countries, with direct consequences for ADA assay validation scope, cut-point frameworks, and sampling schedules in global programs. All assays and data discussed in these articles are for Research Use Only.

The TDM coverage this month spans biologics broadly and IBD specifically. One article frames why trough concentrations have become central to biologic research, while another examines the reactive-versus-proactive timing debate for anti-TNF monitoring in inflammatory bowel disease. A third looks at what biosimilar switching means in practice for drug-level and ADA assay applicability, and a fourth addresses the expanding demand for validated TDM assays as biosimilar ustekinumab moves earlier in the Crohn's disease treatment algorithm. Each of these is grounded in the pharmacokinetic and immunogenicity evidence that labs need to keep pace with a rapidly evolving biosimilar class.

Rounding out the digest are two foundational pieces on ELISA design and validation, covering assay formats, the principles that link a binding event to a measurable signal, and the specific validation parameters that separate reproducible research data from data that cannot be built upon. A standalone article on anti-drug antibody testing makes the case for embedding ADA assays in every biologic workflow, covering both detection and the interpretation of results in the context of drug levels and loss of response.