Biopharmaceuticals need adaptable regs industry group tells EC

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Related tags: European commission, European union

Biopharmaceuticals need adaptable regs
Biopharmaceuticals need adaptable regs
EBE has called on European lawmakers to develop more adaptable registration pathways that are suited to biopharmaceuticals and personalised medicines.

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 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.

Biopharmaceutical reimbursement

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​.”

Related topics: Markets & Regulations, Bio-Outsourcing

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