Biosimilars Industry Urges Improved UK Evaluation Process
Follows ‘Milestone’ NICE Decision On Use Of Biosimilars For Moderate Arthritis
A more efficient system to pave a path to market for biosimilars is needed in the UK, the British Biosimilars Association has urged, as it welcomed recent moves to broaden the use of adalimumab, etanercept and infliximab for treating moderate as well as severe rheumatoid arthritis.
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The UK government’s new Life Sciences Vision “entirely ignores” the off-patent industry, representing an “astonishing” snub given the value of the sector to the NHS and its critical role in fighting the COVID-19 pandemic, according to BGMA chief Mark Samuels.
A decision by the UK’s NICE opens the door to broaden the use of adalimumab, etanercept and infliximab by using them to treat moderate as well as severe rheumatoid arthritis.
Updated guidance on the UK’s new licensing pathway for biosimilars – which will typically not require comparative efficacy data – has been published by the MHRA after a stakeholder consultation, receiving a warm welcome from the off-patent industry both locally and internationally.