Brexit bad for biosimilar developers says new industry group

21-Apr-2016 - Last updated on 22-Apr-2016 at 12:57 GMT

Brexit bad for business bemoans brand-new biosimilars body

Brexit would create regulatory uncertainty, delay the launch of biosimilars and prevent NHS cost savings according to the newly founded British Biosimilars Association (BBA).

The organisation – set up by the British Generic Manufacturers Association (BGMA) to represent biosimilar developers – predicted UK withdrawal from the European Union (EU) would be negative for the industry.

Chairman Tim de Gavre told us “we believe that Brexit would be a bad deal for Biosimilars. It would bring significant uncertainty both to approvals and launches of biosimilars.

“This uncertainty could delay market entry and potentially deny the NHS significant cost savings from these new products as well as deny opportunities and jobs for companies that want to compete in the Biosimilars market.”

At present none of the seven biosimilars available in the UK – versions of somatropin, follitropin alfa, filgrastim, infliximab, epotein alfa, insulin glargine and etanercept – are produced locally.

This is also likely to be an issue if there is an ‘out’ vote on June 23 according to de Gavre, who said importing biosimilars produced on the European mainland would be more complex and costly, thereby making the UK a less attractive market.

“Brexit introduces uncertainty. Uncertainty is bad for manufacturers and bad for the NHS. We see Brexit as potentially negative for Biosimilars. It could also impact Britain as a clinical trial centre and potentially also reduce companies willingness to conduct research in the UK.”

UK trails EU in adoption of biosimilars

The UK already trails the rest of the EU in its adoption of biosimilars.

According to the data from IMS health, biosimilar versions of epoetin-based anaemia meds hold 7% of market. In the rest of the EU such products hold an average 43% share of the market.

de Gavre also cited biosimilar infliximab as another product in which the UK trials Europe.

“The use of biosimilar infliximab in the UK is still only around 30% of the total infliximab use. In other countries such as Norway and Denmark, Biosimilar use of infliximab is 70 – 90% of the total infliximab use.”

The BBS’s aim is to increase use of biosimilars. Part of this will involve attending upcoming meetings chaired by Keith Ridge, NHS England’s Chief Pharmaceutical Officer, during which ways to strengthen the UK market will be discussed.

de Gavre said: “We want to ensure that while the NHS is driving cost savings from biosimilars, this is done in a responsible way that ensures the UK remains an attractive market for future biosimilar launches.

“It cannot be all about price, biosimilars have much to offer in improving and widening patient access. We will also work with the NHS to develop effective educational initiatives that remove barriers and enhance confidence in using biosimilars.”