Italy’s early access system is mainly used for unapproved uses of authorized medicines, and is driven by clinicians, rather than companies.

Regulators should take more of a role in decisions on biosimilar switching and substitution, and international interchangeability practices should be brought into line, delegates at Medicines for Europe’s recent biosimilars conference heard.

A new survey has shown wide differences in patient access to new medicines across, and even within, European countries, with time to access after drug approval ranging from 100 to 1,000 days. Industry has put the blame on factors such as duplicative clinical assessments, the length of HTA processes, and local formulary decisions.

A second complaint has been filed, this time in Belgium, over the “excessive” price hike on Leadiant’s CDCA-containing drug for the rare genetic disorder, CTX.

The biosimilars industry in Europe will face a struggle over the next few years as the longer-term sustainability of the market is threatened by a dearth of big biologic patent expiries and a growing number of new innovative drugs targeted at smaller patient populations. The Pink Sheet spoke to Adrian van den Hoven and Marc-Alexander Mahl of the generics and biosimilar medicines association, Medicines for Europe, about the sector’s key challenges and how they can be tackled.