UK Allows Interchangeability of Biosimilars
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said it will allow the interchangeability of biosimilars, in a final guidance that adopts a similar approach to that taken earlier this year by the European Medicines Agency.
Once authorized, a biosimilar product is interchangeable with the reference product, which means a prescriber can choose the biosimilar medicine over the reference product and expect to achieve the same therapeutic effect, the agency said.
All biological medicines, including biosimilars, should be prescribed by brand name, MHRA said, adding that substitution at the pharmacy level without consulting the prescriber is not permitted for biological medicines, including biosimilars.
November 11, 2022