FOI release

Biosimilar product, GOBIVAZ 100 mg solution for injection in pre-filled syringe (PL 56734/0027).

Case reference FOI2026/00276

Received 9 March 2026

Published 7 May 2026

Request

The request was to gain clarity on the UK reference product used for the approved Biosimilar product, GOBIVAZ 100 mg solution for injection in pre-filled syringe (PL 56734/0027). The outcome stated that the product, Simponi 100mg Solution for Injection in a prefilled syringe, was grandfathered. However, when searching the licence number provided (PLGB 00242/0658), the search lists this as the pre-filled pen product, as opposed to the pre-filled syringe presentation. As the purpose of the request was to clarify the pre-filled syringe reference product used – please could you kindly confirm this?

Response

See attached

Documents

• FOI2026_00276 (redacted).pdf (580.2 KB)

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