In this week’s pharma news, GSK calls for Brexit specifics, UK biosimilars market boom, US FDA launches drug info App and more…
GSK asks for Brexit details
Emma Walmsley, CEO of UK-based drug firm GSK, has welcomed the idea of a Brexit transition deal, but called for more information on the process.
Earlier this month UK and EU negotiators agreed a draft transition deal having reached accord on the timing on the UK’s withdrawal from the EU and certain aspects of citizen’s rights. A number of key issues remain unresolved.
Speaking with the BBC last Monday Walmsley said, “We certainly welcome this pragmatic approach to transition, it is absolutely critical to secure the supply of medicines and vaccines to the people here and in Europe who need them.
“But we are also looking forward to more precision on the details of the end-stage of the relationship” she said.
Earlier this month GSK said preparing for Brexit would cost it £70m over the next few years. The costs are related to retesting medicines, transferring marketing authorizations to the EU and changing manufacturing licenses.
In other news, GSK announced it is no longer interested in buying Pfizer’s consumer healthcare business.
Bye, bye EU supply
One in seven EU manufacturers have moved UK operations elsewhere over concerns about post Brexit disruption according to a survey by the Chartered Institute of Procurement and Supply (CIPS).
The survey of procurement professionals – the third CIPS has completed since the UK referendum – also revealed that 9% of UK firms have lost contracts, or had them cancelled, as a direct result of Brexit.
UK biosimilar drug market outpacing US
UK use of biosimilars – versions of biologic drugs that have lost patent protection – is far higher than in the US according a Reuters report.
NHS data released last week show the UK saved £80m last year by using biosimilars.
The situation in the US is very different where rebates offered to insurers by original-brand drug makers has created barriers to use according to Reuters.
The road to Amsterdam
The EMA has published a new tool to help drug manufacturers keep track of its relocation to Amsterdam.
The currently London-based agency said it was releasing the tool (available here) because it is “committed to giving stakeholders and the public full visibility of the relocation project. The tracking tool will allow all interested parties to follow the progress made.”
The EMA also confirmed it will move from London to Amsterdam before 29 March 2019, which is when the UK will withdraw from the European Union (EU).
US FDA goes mobile with drug info app
The US FDA has launched a mobile app that provides drug labelling information.
According to the agency users can search for “information based on product name, active ingredient or application number using a single search box.”
However, for labelling supplements and approval letters people will still need to visit the organisation’s website.
Also in the news
The European Commission (EC) may encounter cultural hurdles as it tries to harmonize health technology assessments in Europe according to an opinion piece in Pharmaphorum.
STAT reports that the first dose of Spark Therapeutics’ retinal dystrophy gene therapy Luxturna has been administered. According to the publication, medical staff were concerned about handling the $425,000-a-vial drug.