The comments come days after the European Biopharmaceutical Enterprises (EBE) rejected the conclusions of a European Commission (EC) report on the use of 'omics' technologies in the development of biopharmaceuticals.
In the report the Commission identified asserted that regulations for small molecule drugs are flexible enough to adapt to biopharmaceuticals.
EBE spokesman Philip Rye told BioPharma-reporter.com that: “The biggest challenges in the field of personalised medicines are the need for faster, adaptive and ‘fast track’ registration pathways.”
He explained that personalised medicines need adaptability because it is likely that – during development – biomarkers and diagnostics will be used to identify patients who derive more benefit than the wider patient population, which may result in protocol changes.
Reimbursement is another area in which EBE says the C still has more work to do.
Rye said that: “There are multiple health technology assessments (HTA) submission systems across countries, or even regions within countries, [and reviews conducted by them can have] variable outcomes based on the same data, different pathways for therapeutics and diagnostics.
“This is highly problematic when both are required for patients to benefit from personalised medicines. So a joint assessment is what EBE advocates.”
Similarly, the industry group also wants reviews to adopt an aligned approach to HTAs of companion diagnostic products according to Rye.
“EBE’s position is that if medicines are reimbursed, then a reimbursement of the diagnostic component should be a given too.”