Samsung announced its version of Humira – known as SB5 – had been accepted for review late night, explaining that its approval request included data from a 52-week study that showed the biosimilar is as safe and effective as the originator drug.
The two previous biosimilars Samsung had accepted by the European Medicines Agency (EMA) - Benepali (etanercept) its version of Amgen’s Enbrel and Flixabi (infliximab) its version of Janssen’s Remicade – both went on to be approved.
As with those products, if SB5 is approved it will be marketed and distributed by Samsung’s partner Biogen.
UK base for MAA?
Samsung Bioepis’ European operation is registered in London, UK.
When the firm set up shop in England’s capital last December, it told us the division “was established to support our operations in Europe.”
It added that: “One of SBUK's primary responsibilities will be to act as Samsung Bioepis' market authorization holder (MAH) upon approval of our biosimilar products in the European Union (EU)."
The firm did not respond when we asked if this plan will change as a result of the UK vote to withdraw from the European Union.
Whether the UK does leave the EU – a move known as Brexit – is unclear as is the impact of such a decision of Europe’s regulatory landscape.
One likely impact is that the EMA – a decentralised agency that carries out technical, scientific or managerial tasks related to medicines to help EU institutions make and implement policies - will relocate from its current base in London.
In May an EU spokesman told us all decentralised agencies are located in EU member states.