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NOR-SWITCH Results ‘Concerning’ In Crohn’s Disease, Says Janssen

 
• By Ian Schofield

Janssen Biotech says that the NOR-SWITCH study on switching from Remicade to biosimilar infliximab raises “significant questions” over safety and efficacy in patients with Crohn’s disease, and does not support interchangeability.

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How far should biosimilars be interchangeable?

The results of NOR-SWITCH, the Norwegian government-sponsored study on switching patients from Johnson & Johnson’s Remicade (infliximab) to Celltrion’s biosimilar version Remsima (CT-P13), have generated a great deal of controversy since they were published last month, especially over how far the data support the safety of switching.

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More from Biosimilars

Sandoz Slims Down Pembrolizumab Trial As Regulators Streamline Requirements

 
• By Dave Wallace

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

 
• By Dean Rudge

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

 
• By Dave Wallace

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

 
• By Dave Wallace

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.

More from Products

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

 
• By Dave Wallace

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

 
• By Dean Rudge

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

 
• By Dean Rudge

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