UK Could Become ‘World Leader’ On Biosimilar Regulation

Country’s Reduced-Data Pathway Could Be Followed By EU And US

The UK is putting itself in a position to play a leading role in global biosimilars regulation, thanks to a proposed new registration pathway that will not require comparative efficacy data, delegates to a Westminster Health Forum online conference heard earlier today.

UK flag world map
The UK is poised to play a leading role on the global biosimilars stage • Source: Alamy

A new streamlined licensing pathway for biosimilars that has been proposed by the UK’s Medicines and Healthcare products Regulatory Agency offers the country the opportunity to play a world-leading role in biosimilars regulation, delegates to a Westminster Health Forum online conference on priorities for biosimilars in the National Health Service heard earlier today.

More from Biosimilars

Who’s Hired? Alvotech Appoints Strategy And Quality Chiefs

 
• By 

Alvotech has named two new key executives, while Biosimilars Canada has elected its 2025 leaders and the AAM has welcomed the new FDA commissioner in the US.

Richter Confirms European Tocilizumab Filing

Gedeon Richter has filed its Mochida-partnered tocilizumab biosimilar rival to RoActemra with the European Medicines Agency. But with several biosimilars already having won approval, the market could be competitive.

Accord’s Denosumab Biosimilars Get Thumbs-Up From EMA

 
• By 

Accord received positive opinions for its Prolia and Xgeva biosimilars at the latest meeting of the EMA’s CHMP. Meanwhile, Celltrion picked up a nod for another Stelara biosimilar, while Rechon Life Science withdrew an application for human insulin.

Celltrion Plans Multiple US Biosimilar Launches In An ‘Exciting And Momentous’ Year

 
• By 

With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.

More from Products

Celltrion Plans Multiple US Biosimilar Launches In An ‘Exciting And Momentous’ Year

 
• By 

With Celltrion having just received approval for its US Actemra (tocilizumab) biosimilar and having just launched its ustekinumab rival to Stelara – and with the introduction of the Korean developer’s denosumab rivals to Prolia and Xgeva just around the corner – 2025 is set to be a busy year, Celltrion USA chief commercial officer Thomas Nusbickel tells Generics Bulletin.

Alvotech Reveals Ramp-Up In Development As Sales Explode In 2024

 
• By 

With sales and profits shooting up in 2024, Alvotech has revealed plans to rapidly accelerate development to add between four and six programs to its pipeline of biosimilars every year, while at the same time unveiling details of several new brands that it will be seeking to challenge. The firm has also set out longer-term financial targets that anticipate more than trebling its revenues in the next three years.

Dr Reddy’s Bags Rights To Two More Biosimilars In Deal With Bio-Thera

 
• By 

India’s Dr Reddy’s and China’s Bio-Thera have struck a deal covering ustekinumab and golimumab biosimilars in multiple markets in south-east Asia.