NICE Decision On Arthritis Opens Door For Biosimilars

UK Recommends Treating Moderate Rheumatoid Arthritis With Three Biologic Molecules

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.

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The NICE decision opens the door for biosimilars to treat more UK patients • Source: Alamy

Final draft guidance published by the UK’s National Institute for Health and Care Excellence has opened the door for greater use of biosimilar adalimumab, etanercept and infliximab in England by recommending that these biologic molecules be used to treat moderate as well as severe rheumatoid arthritis.

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Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
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As Sandoz continues development of its planned pembrolizumab biosimilar rival to Keytruda, the company has revealed plans to slim down its Phase III trial amid the latest moves from regulators towards streamlining clinical study requirements for biosimilar registration.

Amgen’s Aflibercept Starts Strong As Regeneron Counts Cost Of Eylea Competition

 
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Amgen told investors during its 1 May first-quarter earnings call that its Pavblu biosimilar to Eylea 2mg had flown out of the gates, while Regeneron admitted “some difficult news related to our retinal franchise.”

BGMA Becomes Medicines UK

 
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The UK generics and biosimilars industry will now be represented by Medicines UK, the new name for the former British Generic Manufacturers Association.

J&J Denied Injunction Over Private-Label Ustekinumab In US

 
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Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

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J&J Denied Injunction Over Private-Label Ustekinumab In US

 
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Stelara originator J&J has been denied in its initial attempt to prevent Samsung Bioepis and ustekinumab biosimilar partner Sandoz from selling a private-label version of the product through a PBM in the US.

UK Forxiga SPCs Wiped Out As Trio Succeed With Plausibility Attack

 
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Generic competition to AstraZeneca’s blockbuster SGLT2 inhibitor Forxiga (dapagliflozin) treatment for diabetes may hit England and Wales earlier than 2028 after a pair of SPCs were invalidated following proceedings initiated by a trio of generics manufacturers.

What’s Next? Five Things To Look Out For In May

 
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Generics Bulletin previews the most noteworthy and anticipated events for May 2025.