British health technology assessor OKs Stelara biosimilar

15 January 2025

Formycon (FSE: FYB) and its commercialization partner, fellow German firm Fresenius Kabi, have received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Otulfi (ustekinumab).

The biosimilar, referencing Johnson & Johnson’s (NYSE: JNJ) Stelara, targets inflammatory conditions such as Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

The decision follows earlier regulatory nods in the USA, European Union and Canada.

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