Biography
Biography: Dipti Gulati,
Abstract
The UK decided to leave the European Union on 23 June2016, but will Brexit change Biosimilar market?
One group believes that that Brexit UK will have a significant impact on Biosimilar market in UK because UK currently don’t have a regulatory pathway to approve Biosimilars. The approval process for Biosimilars is currently carried out through a Centralized procedure with the EMA. Additionally, none of the seven Biosimilars available in UK are manufactured locally. Brexit could result in disruption of supply chain, additional importation testing, additional recertification requirements after importing, new import/export charges and uncertainty regarding regulatory strategy.Others optimistic group pinpoints that the EMA is currently headquartered in London and relocation of the headquarter to other EU country will not happen soon. Furthermore, UK may not want Drug manufacturers to follow two separate regulatory pathways for Biosimilars. It is beneficial for both UK and EU to remain part of same regulatory scheme. How Brexit will impact regulatory pathway and approval of Biosimilars, is yet to be determined. Author will present the impact of Brexit on Biosimilar market.