Biosimilar Makers Take On ‘Huge’ Barriers To A Sustainable European Market
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.
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A manufacturing waiver to allow EU-based companies to produce generics and biosimilars during the SPC term is expected to gain final approval shortly. However, the European Commission will be watching closely to see whether the provision is actually used by industry.
Speakers from several EU countries at last week's Medicines for Europe conference discussed the reasons behind the often wide inter-country disparities in biosimilar usage and the policies they are pursuing to try to remedy the situation.
Members of the European Parliament were told that once the list was out, work would begin on identifying the products most vulnerable to supply chain problems.