Sean Milmo

Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.

How involved should HTA bodies be in assessing cost effectiveness and reimbursements?

More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.

Finalizing GMP requirements and quality standards for the development, manufacture, and clinical testing of ATMPs in the EU is proving to be a complex task.