Roche has been asked to provide new clinical data to support its efforts to seek National Institute for Health and Clinical Excellence (NICE) approval for RoActemra.
The UK regulatory body has published draft guidance requesting that information be provided to help it to better assess the benefits of the arthritis drug.
RoActemra has been submitted for approval as a therapy for systemic juvenile idiopathic arthritis in children and young people aged two years and older, for whom previous treatments have proven ineffective.
NICE is seeking detailed information of RoActemra's performance in comparison to alternative therapies, as well as data on potential side effects in the long term.
Professor Carole Longson, health technology evaluation centre director at NICE, said: "In the meantime, we welcome comments from patients, and their carers and families, and clinicians as part of our public consultation on the committee's provisional recommendations."
Last month, Roche's lung cancer drug Tarceva was recommended by Europe's Committee for Medicinal Products for Human Use for approval as a first-line therapy.See all the latest jobs in Pharmaceutical