Newsletter
The monthly digest
A summary of every article we published, once a month. Subscribe via the form in the footer.
August 2026
AlpinaBioTech Digest - August 2026
This month's six articles center heavily on biosimilar monitoring, where the measurement questions are becoming more pressing as real-world switching data accumulate without systematic therapeutic drug monitoring or anti-drug antibody testing built in. Two pieces examine anti-TNF and anti-CD20 biosimilars directly: one reviews what a post-switch trough level drop in pediatric adalimumab cohorts means for laboratory protocols, and another draws on the BRAVO multicenter cohort to argue that equivalent six-month clinical outcomes in rituximab-treated AAV patients reinforce, rather than reduce, the rationale for structured pharmacokinetic and immunogenicity monitoring. All assays and products described are for Research Use Only.
6 articles
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 A companion piece examines how a May 2026 scoping review in JAMA Health Forum and the FDA's March 2026 Revision 4 draft guidance together expose persistent inconsistencies in immunogenicity requirements across 19 countries, with direct consequences for ADA assay validation scope,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