FOI release

Golimumab reference product query

Case reference FOI2026/00084

Received 28 January 2026

Published 9 March 2026

Request

We are requesting feedback regarding the UK reference product used for the approved Biosimilar product, GOBIVAZ 100 mg solution for injection in pre-filled pen (PL 56734/0027). On review of the public assessment report, published on the MHRA products website (https://mhraproducts4853.blob.core.windows.net/docs/c7ed9e0c96f5a9f982d3281b0f6194e9c180c077), the reference product cited is Simponi 100 mg solution for injection in pre-filled syringe. It is our understanding that this product was licensed via the centralized procedure, however, post-Brexit this licence was not grandfathered into a UK licence. Following implementation of the Windsor Framework guidance, EU marketing authorisations that were not converted to GB MAs are no longer accepted as reference medicinal products. Based on the Gobivaz PAR, this guidance was applicable at the time of MAA submission/approval. Additionally, there is no reference to bridging work being performed within the PAR. Therefore, we are requesting clarity on the approach used in this case, to use Simponi 100 mg solution for injection in pre-filled syringe, as a UK reference product for a biosimilar MAA in the UK.

Response

See attached

Documents

• FOI2026_00084 (redacted).pdf (613.3 KB)

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