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The monthly digest
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July 2026
AlpinaBioTech Digest - July 2026
This month's articles cover three areas with direct implications for laboratories running immunogenicity and therapeutic drug monitoring assays. All content is published for Research Use Only.
3 articles
June 2026
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 A companion piece examines how a May 2026 scoping review in JAMA Health Forum and the FDA's March 2026 Revision 4 draft guidance together expose persistent inconsistencies in immunogenicity requirements across 19 countries, with direct consequences for ADA assay validation scope,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.
10 articles