Consequences of Brexit on Biosimilars

Brexit, the United Kingdom's withdrawal from the European Union (EU), has had several consequences on biosimilars. Prior to Brexit, the EU provided a unified regulatory framework for the approval and market access of biosimilars across member states. However, with the UK's departure, the Medicines and Healthcare products Regulatory Agency (MHRA) now oversees the regulation and approval of biosimilars specifically for the UK market. This has led to additional regulatory complexities and increased costs for biosimilar manufacturers who need to navigate separate approval processes for the UK and EU markets. Moreover, the divergence in regulations between the UK and the EU has resulted in uncertainties regarding mutual recognition and potential delays in launching biosimilars in both regions. These consequences have introduced challenges for biosimilar developers and impacted patient access to more affordable treatment options in both the UK and EU markets.

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