EMA accepts third Samsung Bioepis biosimilar for review

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)​."

Brexit​

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.