UK – MHRA updates biosimilar guidance to allow interchangeability between products

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its 2021 guidance on biosimilars to allow interchangeability between biosimilars if they use the same reference medicinal product (RP).

On 6 November, the British regulatory agency updated a 2021 document titled Guidance on the licensing of biosimilar products. It has expanded the interchangeability section of the document to account for biosimilars that have the same RP.

“Once authorized, a biosimilar product is considered to be interchangeable with their RP, which means a prescriber can choose the biosimilar medicine over the RP (or vice versa) and expect to achieve the same therapeutic effect,” according to the guidance. “Likewise, a biosimilar product is considered to be interchangeable with another biosimilar to the same RP.

“As a result of interchangeability, switching patients from one product to another (RP or biosimilar) has become clinical practice,” the agency added. “The decision rests with the prescriber in consultation with the patient, in line with the principles of shared decision making; both need to be aware of the brand name of the product received.”…